Subset Code Subset Name Concept Code NCIt Preferred Term NCIt Definition PQCMC Preferred Term PQCMC Synonyms(s) PQCMC Definition SPL Preferred Term SPL Synonym (s) C133805 FDA Pharmaceutical Quality/CMC Terminology C115123 Abbreviated New Animal Drug Application Data submitted to an abbreviated new animal drug application. Abbreviated New Animal Drug Application PQCMC data submitted to an abbreviated (generic) new animal drug application. C133805 FDA Pharmaceutical Quality/CMC Terminology C73113 Abbreviated New Drug Application Data submitted to an abbreviated new drug application. Abbreviated New Drug Application PQCMC data submitted to an abbreviated (generic) new human drug application. C133805 FDA Pharmaceutical Quality/CMC Terminology C14182 Animal A living organism that has membranous cell walls, requires oxygen and organic foods, and is capable of voluntary movement, as distinguished from a plant or mineral. Animal A living organism that has membranous cell walls, requires oxygen and organic foods, and is capable of voluntary movement, as distinguished from a plant or mineral. C133805 FDA Pharmaceutical Quality/CMC Terminology C18634 Animal Sources Indicates that a product is derived from an animal. Animal-derived indirectly Indicates that a product is derived from an animal. C133805 FDA Pharmaceutical Quality/CMC Terminology C25425 Approval Acceptance as satisfactory by an authoritative body; established by authority; given authoritative approval. Approved Acceptance as satisfactory by an authoritative body; established by authority; given authoritative approval. C133805 FDA Pharmaceutical Quality/CMC Terminology C60819 Assay A qualitative or quantitative analysis performed to determine the amount of a particular constituent in a sample or the biological or pharmacological properties of a drug. Assay Tests which measure the content of the active ingredient in the drug substance or drug product. Synonymous with strength or purity which is commonly used of define the content of the active ingredient in a drug product. [Source: Adapted from ICH Q6A and Q6B] Note: chiral purity, preservative content, Anti-Oxidant Concentration, Chelate Concentration, isomeric ratio. C133805 FDA Pharmaceutical Quality/CMC Terminology C45420 Biochemical Activity A measurable amount of a specific function or role performed by a entity in a biophysical process, biochemical reaction, or biochemical process. Activity A measure of a property related to therapeutic or biological effect. Example, enzyme activity. C133805 FDA Pharmaceutical Quality/CMC Terminology C158425 Biological Properties Any effect a given chemical has on a living organism. Biological Properties Any effect a given material has on a living organism (e.g., microbial limits, endotoxin). C133805 FDA Pharmaceutical Quality/CMC Terminology C71778 Biologics License Application A formal submission to FDA from any legal person or entity to obtain permission for manufacturing and marketing a biological product subject to licensure under section 351 of the Public Health Service Act. A biologics license application must contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product, sufficient for the FDA to determine that the establishment and the product meet applicable requirements to ensure the continued safety, purity, and potency of the product, including but not limited to GMPs. Biologics License Application PQCMC data submitted to a biologics license application. C133805 FDA Pharmaceutical Quality/CMC Terminology C134005 Central File Number A seven digit number assigned by the Food and Drug Administration (FDA). CFN A seven digit number assigned by the Food and Drug Administration (FDA). C133805 FDA Pharmaceutical Quality/CMC Terminology C48807 Chemical A substance with a defined atomic or molecular structure that results from, or takes part in, reactions involving changes in its structure, composition, or properties. Chemical A substance with a defined atomic or molecular structure that results from, or takes part in, reactions involving changes in its structure, composition, or properties. C133805 FDA Pharmaceutical Quality/CMC Terminology C158423 Chemical Impurity Any unwanted organic, inorganic, and residual solvents in drug substances and final products. Impurities Analytical procedures that determine the presence of a component of the material that is not the chemical entity defined as the material. C133805 FDA Pharmaceutical Quality/CMC Terminology C17771 Chemical Properties General term for compositional, structural, and reactivity- affecting qualities of chemical compounds. Chemical Properties A characteristic of a material that is observed during a reaction in which the chemical composition or identity of the material is changed (e.g., combustibility, solubility, acidity/basicity). C133805 FDA Pharmaceutical Quality/CMC Terminology C96164 Code of Federal Regulations Method A method described in the Code of Federal Regulations. CFR A method described in the Code of Federal Regulations. C133805 FDA Pharmaceutical Quality/CMC Terminology C96102 Compendial Method Standardized methods and specification testing for generic pharmaceutical raw materials and finished products. Compendial Standardized methods and specification testing for generic pharmaceutical raw materials and finished products. C133805 FDA Pharmaceutical Quality/CMC Terminology C80262 Conformance Correspondence in form or appearance. Conforms Correspondence in form or appearance. C133805 FDA Pharmaceutical Quality/CMC Terminology C134003 Data Universal Numbering System A proprietary system developed and regulated by Dun & Bradstreet that assigns a unique nine digit numeric identifier to a single business entity location. DUNS A proprietary system developed and regulated by Dun & Bradstreet that assigns a unique nine digit numeric identifier to a single business entity location. C133805 FDA Pharmaceutical Quality/CMC Terminology C133998 Does Not Conform An observation that the item of interest does not match required specifications. Does not conform An observation that the item of interest does not match required specifications. C133805 FDA Pharmaceutical Quality/CMC Terminology C168628 Drug Component Mass The mass of the active and inactive substances in a drug component. Mass The amount of active and/or inactive substance of a drug component. C133805 FDA Pharmaceutical Quality/CMC Terminology C134021 Drug Product Specification The specification which is applied to the drug product. Drug Product The specification which is applied to the drug product. C133805 FDA Pharmaceutical Quality/CMC Terminology C134022 Drug Substance Specification The specification which is applied to the drug substance. Drug Substance The specification which is applied to the drug substance. C133805 FDA Pharmaceutical Quality/CMC Terminology C48793 Equivalent A person or thing equal to another in value or measure or force or effect or significance etc; being essentially equal to something. EQ C133805 FDA Pharmaceutical Quality/CMC Terminology C134004 Facility FDA Establishment Identifier A unique identifier assigned by the Food and Drug Administration (FDA) to track inspections of a regulated establishment or facility. They are also used to track generic drug user fee acts (GDUFA) facility fee payments. FEI A unique identifier assigned by the Food and Drug Administration (FDA) to track inspections of a regulated establishment or facility. They are also used to track generic drug user fee acts (GDUFA) facility fee payments. C133805 FDA Pharmaceutical Quality/CMC Terminology C115122 Generic Investigational New Animal Drug File Data submitted to a generic investigational new animal drug file. Generic Investigational New Animal Drug File PQCMC data submitted to a generic investigational new animal drug file. C133805 FDA Pharmaceutical Quality/CMC Terminology C124085 Geopolitical Entities, Names, and Codes Terminology Codes for the representation of names of countries and their subdivisions that have been approved by the US Board on Geographic Names. C133805 FDA Pharmaceutical Quality/CMC Terminology C61584 Greater Than A statement about the relative size or order of two objects specifying that an object of interest exceeds another object in quantity or measure or value or status. MT (more than) A statement about the relative size or order of two objects specifying that an object of interest exceeds another object in quantity or measure or value or status. C133805 FDA Pharmaceutical Quality/CMC Terminology C61583 Greater Than or Equal To A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest exceeds the other object in one of these ways. NLT (not less than) A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest exceeds the other object in one of these ways. C133805 FDA Pharmaceutical Quality/CMC Terminology C14225 Human The bipedal primate mammal, Homo sapiens; belonging to man or mankind; pertaining to man or to the race of man; use of man as experimental subject or unit of analysis in research. Human The bipedal primate mammal, Homo sapiens; belonging to man or mankind; pertaining to man or to the race of man; use of man as experimental subject or unit of analysis in research. C133805 FDA Pharmaceutical Quality/CMC Terminology C80440 Humanitarian Device Exemption A premarket submission to FDA for a device intended to benefit patients by treating or diagnosing a condition affecting fewer than 4,000 individuals in the United States per year. An HDE is similar in form and content to a premarket approval (PMA) but is exempt from the effectiveness requirements of a PMA. Humanitarian Device Exemption (HDE) PQCMC data submitted for an HDE application. C133805 FDA Pharmaceutical Quality/CMC Terminology C14227 Insect A taxonomic class of arthropods that includes praying mantises, dragonflies, grasshoppers, true bugs, flies, bees, wasps, ants, butterflies, moths, and beetles. Insect A taxonomic class of arthropods that includes praying mantises, dragonflies, grasshoppers, true bugs, flies, bees, wasps, ants, butterflies, moths, and beetles. C133805 FDA Pharmaceutical Quality/CMC Terminology C82667 Investigational Device Exemption Allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval application or a Premarket Notification submission to the Food and Drug Administration. Investigational Device Exemption PQCMC data submitted to an investigational device exemption. C133805 FDA Pharmaceutical Quality/CMC Terminology C96091 Investigational New Animal Drug File Data submitted to an investigational new animal drug file. Investigational New Animal Drug File PQCMC data submitted to an investigational new animal drug file. C133805 FDA Pharmaceutical Quality/CMC Terminology C96090 Investigational New Drug Application Data submitted to an investigational new human drug application. Investigational New Drug Application PQCMC data submitted to an investigational new human drug application. C133805 FDA Pharmaceutical Quality/CMC Terminology C61585 Less Than A statement about the relative size or order of two objects specifying that an object of interest is smaller than another object in quantity or measure or value or status. LT (less than) A statement about the relative size or order of two objects specifying that an object of interest is smaller than another object in quantity or measure or value or status. C133805 FDA Pharmaceutical Quality/CMC Terminology C61586 Less Than or Equal To A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest is smaller than the other object in one of these ways. NMT (not more than) A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest is smaller than the other object in one of these ways. C133805 FDA Pharmaceutical Quality/CMC Terminology C138993 Material Identification Tests that establishes the characteristic and uniqueness of the substance of interest and should be able to discriminate between compounds of closely related structures which are likely to be present. Identification Tests that establishes the characteristic and uniqueness of the substance of interest and should be able to discriminate between compounds of closely related structures which are likely to be present. [Source: ICH Q6A] C133805 FDA Pharmaceutical Quality/CMC Terminology C14329 Microorganism A microscopic organism. The term microorganism may refer to a prokaryote or eukaryote, and may be a unicellular or multicellular organism. All taxonomic kingdoms contain microorganisms. Microbial A microscopic organism. The term microorganism may refer to a prokaryote or eukaryote, and may be a unicellular or multicellular organism. All taxonomic kingdoms contain microorganisms. C133805 FDA Pharmaceutical Quality/CMC Terminology C96092 New Active Ingredient Data submitted for an active ingredient. New Active Ingredient PQCMC data submitted for an active ingredient, could be PQCMC data for an active ingredient submitted in a drug application, or a Master File. C133805 FDA Pharmaceutical Quality/CMC Terminology C72901 New Animal Drug Application Data submitted to a new animal drug application. New Animal Drug Application PQCMC data submitted to a new animal drug application. C133805 FDA Pharmaceutical Quality/CMC Terminology C72899 New Drug Application A regulatory document submitted to the FDA proposing the approval of a new drug to be marketed and sold in the U.S. It includes supporting data from both animal and human studies that was initially provided in the Investigational New Drug application (IND). New Drug Application PQCMC data submitted to a new human drug application. C133805 FDA Pharmaceutical Quality/CMC Terminology C48660 Not Applicable Determination of a value is not relevant in the current context. Not Applicable NA Determination of a value is not relevant in the current context. C133805 FDA Pharmaceutical Quality/CMC Terminology C134011 Not Approved A specification that has not yet been approved. Not Approved A specification that has not yet been approved. C133805 FDA Pharmaceutical Quality/CMC Terminology C168639 PQ/CMC Application Type Terminology A category of terminology used to qualify the information pertaining to application types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents. PQ/CMC Application Type Terminology C133805 FDA Pharmaceutical Quality/CMC Terminology C133851 PQ/CMC Conformance to Criteria Terminology A category of terminology used to qualify the information pertaining to conformance to criteria in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents. PQ/CMC Conformance to Criteria Terminology C133805 FDA Pharmaceutical Quality/CMC Terminology C133858 PQ/CMC Interpretation Code Terminology A category of terminology used to qualify the information pertaining to numeric interpretation codes in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents. PQ/CMC Interpretation Code Terminology C133805 FDA Pharmaceutical Quality/CMC Terminology C133859 PQ/CMC Manufacturing Site Unique Identifier Type Terminology A category of terminology used to qualify the information pertaining to manufacturing site unique identifier types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents. PQ/CMC Manufacturing Site Unique Identifier Type Terminology C133805 FDA Pharmaceutical Quality/CMC Terminology C133862 PQ/CMC Source Type Terminology A category of terminology used to qualify the information pertaining to source types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents. PQ/CMC Source Type Terminology C133805 FDA Pharmaceutical Quality/CMC Terminology C133863 PQ/CMC Specification Status Terminology A category of terminology used to qualify the information pertaining to specification statuses in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents. PQ/CMC Specification Status Terminology C133805 FDA Pharmaceutical Quality/CMC Terminology C133864 PQ/CMC Specification Type Terminology A category of terminology used to qualify the information pertaining to specification types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents. PQ/CMC Specification Type Terminology C133805 FDA Pharmaceutical Quality/CMC Terminology C168624 PQ/CMC Sponsor Identifier Type Terminology A category of terminology used to qualify the information pertaining to sponsor identifier types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents. PQ/CMC Sponsor Identifier Type Terminology C133805 FDA Pharmaceutical Quality/CMC Terminology C168622 PQ/CMC Strength Operator Terminology A category of terminology used to qualify the information pertaining to strength operators in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls. PQ/CMC Strength Operator Terminology C133805 FDA Pharmaceutical Quality/CMC Terminology C168627 PQ/CMC Strength Type Terminology A category of terminology used to qualify the information pertaining to strength types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents. PQ/CMC Strength Type Terminology C133805 FDA Pharmaceutical Quality/CMC Terminology C133807 PQ/CMC Test Category Terminology A category of terminology used to qualify the information pertaining to test categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents. PQ/CMC Test Category Terminology C133805 FDA Pharmaceutical Quality/CMC Terminology C133867 PQ/CMC Test Method Origin Terminology A category of terminology used to qualify the information pertaining to test method origins in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents. PQ/CMC Test Method Origin Terminology C133805 FDA Pharmaceutical Quality/CMC Terminology C133868 PQ/CMC Test Usage Terminology A category of terminology used to qualify the information pertaining to test usage in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents. PQ/CMC Test Usage Terminology C133805 FDA Pharmaceutical Quality/CMC Terminology C158424 Physical Properties Any of the characteristics of a chemical that are not associated with a change in its composition and basic nature, including but not limited to its appearance, texture, color, smell, freezing point, boiling point, melting point, opacity, viscosity and density. Physical Properties Assessments of the characteristics of a material that are not associated with a change in its composition and basic nature, including but not limited to its texture, smell, freezing point, boiling point, melting point, opacity, viscosity and density. C133805 FDA Pharmaceutical Quality/CMC Terminology C14258 Plant Any living organism that typically synthesizes its food from inorganic substances, possesses cellulose cell walls, responds slowly and often permanently to a stimulus, lacks specialized sense organs and nervous system, and has no powers of locomotion. (EPA Terminology Reference System) Plant Any living organism that typically synthesizes its food from inorganic substances, possesses cellulose cell walls, responds slowly and often permanently to a stimulus, lacks specialized sense organs and nervous system, and has no powers of locomotion. (EPA Terminology Reference System) C133805 FDA Pharmaceutical Quality/CMC Terminology C70880 Pre-market Approval Application An application to FDA for a license to market a new device in the United States. Premarket Approval PQCMC data submitted for a PMA application. C133805 FDA Pharmaceutical Quality/CMC Terminology C80442 Premarket Device Notification A premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective as a legally marketed device that is not subject to PMA (Premarket Authorization). Premarket Notification 510(K) PQCMC data submitted for a premarket 510(k) submission. C133805 FDA Pharmaceutical Quality/CMC Terminology C138990 Product Description/Appearance Tests using visual inspection to assess the physical state and color of the drug substance or product. Description An assessment of the physical state (e.g., color, shape, size) of the drug substance or product. [Source: Adapted from ICH Q6A] C133805 FDA Pharmaceutical Quality/CMC Terminology C96103 Proprietary Method An analysis that contains protected intellectual property preventing full disclosure of information about the method and/or restricting or limiting the use or distribution of the method or materials for its performance without express permission or licensing. Proprietary An analysis that contains protected intellectual property preventing full disclosure of information about the method and/or restricting or limiting the use or distribution of the method or materials for its performance without express permission or licensing. C133805 FDA Pharmaceutical Quality/CMC Terminology C133931 Raw Materials/Excipients/Intermediates/Reagents Specification The specification which is applied to the raw materials, excipients, intermediates or reagents. Raw Materials/Excipients/Intermediates/Reagents The specification which is applied to the raw materials, excipients, intermediates or reagents. C133805 FDA Pharmaceutical Quality/CMC Terminology C134029 Release Determination For determination of acceptability for use of a material, drug or a drug substance. Release For determination of acceptability for use of a material, drug or a drug substance. C133805 FDA Pharmaceutical Quality/CMC Terminology C134012 Reported in a CBE or AR The specification may be used without prior approval, and was submitted in a changes being effected (CBE) supplement or an annual report (AR). Reported in a CBE or AR The specification may be used without prior approval, and was submitted in a changes being effected (CBE) supplement or an annual report (AR). C133805 FDA Pharmaceutical Quality/CMC Terminology C54456 SPL Pharmaceutical Dosage Form Terminology Terminology used for representation of the information on pharmaceutical product dosage form in the framework of the Structured Product Labeling documents. C133805 FDA Pharmaceutical Quality/CMC Terminology C168632 SPL UCUM Terminology A list of units of measure adopted by SPL from the Unified Code for Units of Measure (UCUM) list. C133805 FDA Pharmaceutical Quality/CMC Terminology C134030 Stability Determination For determination of maintained performance parameters on storage over time, of a material, drug or a drug substance. Stability For determination of maintained performance parameters on storage over time, of a material, drug or a drug substance. C133805 FDA Pharmaceutical Quality/CMC Terminology C134010 Tentative Approval Provisional approval of a specification. Tentatively Approved Provisional approval of a specification. C133805 FDA Pharmaceutical Quality/CMC Terminology C17998 Unknown Not known, not observed, not recorded, or refused. Unknown Not known, not observed, not recorded, or refused. C124085 Geopolitical Entities, Names, and Codes Terminology C16267 Afghanistan A country in southern Asia, north and west of Pakistan, east of Iran. C124085 Geopolitical Entities, Names, and Codes Terminology C49344 Akrotiri A British Overseas Territory comprising a peninsula on the southern coast of Cyprus. C124085 Geopolitical Entities, Names, and Codes Terminology C16271 Albania A country in southeastern Europe, bordering the Adriatic and Ionian Seas, between Greece and Montenegro. C124085 Geopolitical Entities, Names, and Codes Terminology C16274 Algeria A country in northern Africa, bordering the Mediterranean Sea, between Morocco and Tunisia. C124085 Geopolitical Entities, Names, and Codes Terminology C17739 American Samoa A group of islands in the South Pacific Ocean, between Hawaii and New Zealand and east of Samoa. C124085 Geopolitical Entities, Names, and Codes Terminology C16289 Andorra A country in southwestern Europe, between France and Spain. C124085 Geopolitical Entities, Names, and Codes Terminology C16292 Angola A country in southern Africa, bordering the South Atlantic Ocean, between Namibia and Democratic Republic of the Congo. C124085 Geopolitical Entities, Names, and Codes Terminology C20133 Anguilla A group of islands in the Caribbean Sea, east of the Virgin Islands and north of Saint Kitts and Nevis. C124085 Geopolitical Entities, Names, and Codes Terminology C18007 Antarctica The continent lying mostly south of the Antarctic Circle. C124085 Geopolitical Entities, Names, and Codes Terminology C16303 Antigua and Barbuda A group of islands in the Caribbean Sea, east of Saint Kitts and Nevis. C124085 Geopolitical Entities, Names, and Codes Terminology C16305 Argentina A country in southern South America, bordering the South Atlantic Ocean, between Chile and Uruguay. C124085 Geopolitical Entities, Names, and Codes Terminology C16306 Armenia A country in southwestern Asia, east of Turkey and south of Georgia. C124085 Geopolitical Entities, Names, and Codes Terminology C17884 Aruba An island in the Caribbean Sea, north of Venezuela and west of Curacao. C124085 Geopolitical Entities, Names, and Codes Terminology C123741 Ashmore and Cartier Islands Islands in the Indian Ocean, located midway between northwestern Australia and Timor island. C124085 Geopolitical Entities, Names, and Codes Terminology C16311 Australia The continent and country between the Indian Ocean and the South Pacific Ocean, south of Asia. C124085 Geopolitical Entities, Names, and Codes Terminology C16312 Austria A country in central Europe, northeast of Italy and southeast of Germany. C124085 Geopolitical Entities, Names, and Codes Terminology C16316 Azerbaijan A country in southwestern Asia, bordering the Caspian Sea, between Iran and Russia. C124085 Geopolitical Entities, Names, and Codes Terminology C16321 Bahamas A chain of islands in the North Atlantic Ocean, southeast of Florida and north of Cuba. C124085 Geopolitical Entities, Names, and Codes Terminology C16322 Bahrain An archipelago in the Persian Gulf, on the east coast of Saudi Arabia. C124085 Geopolitical Entities, Names, and Codes Terminology C123742 Baker Island An atoll in the North Pacific Ocean, about halfway between Hawaii and Australia. C124085 Geopolitical Entities, Names, and Codes Terminology C16323 Bangladesh A country in southern Asia, bordering the Bay of Bengal, between Burma and India. C124085 Geopolitical Entities, Names, and Codes Terminology C16324 Barbados An island between the Caribbean Sea and the North Atlantic Ocean, east of Saint Vincent and the Grenadines. C124085 Geopolitical Entities, Names, and Codes Terminology C123743 Bassas da India An atoll in the southern Mozambique Channel that is part of the French Southern and Antartic Lands. C124085 Geopolitical Entities, Names, and Codes Terminology C16372 Belarus A country in eastern Europe, east of Poland and north of Ukraine. C124085 Geopolitical Entities, Names, and Codes Terminology C16329 Belgium A country in western Europe, bordering the North Sea, between France and the Netherlands. C124085 Geopolitical Entities, Names, and Codes Terminology C16331 Belize A country in central America, bordering the Caribbean Sea, between Guatemala and Mexico. C124085 Geopolitical Entities, Names, and Codes Terminology C16333 Benin A country in western Africa, bordering the North Atlantic Ocean, between Nigeria and Togo. C124085 Geopolitical Entities, Names, and Codes Terminology C16334 Bermuda A group of islands in the North Atlantic Ocean, east of South Carolina. C124085 Geopolitical Entities, Names, and Codes Terminology C16336 Bhutan A country in southern Asia, between China and India, east of Nepal and north of Bangladesh. C124085 Geopolitical Entities, Names, and Codes Terminology C16359 Bolivia, Plurinational State of A country in central South America, southwest of Brazil. C124085 Geopolitical Entities, Names, and Codes Terminology C101224 Bonaire, Sint Eustatius and Saba Three islands comprising the Caribbean portion of the Netherlands, north of Venezuela and east of Curacao. C124085 Geopolitical Entities, Names, and Codes Terminology C16361 Bosnia and Herzegovina A country in southeastern Europe, bordering the Adriatic Sea, between Croatia and Serbia. C124085 Geopolitical Entities, Names, and Codes Terminology C16363 Botswana A country in southern Africa, north of South Africa and east of Namibia. C124085 Geopolitical Entities, Names, and Codes Terminology C20104 Bouvet Island An island in the South Atlantic Ocean, south-southwest of the Cape of Good Hope (South Africa). C124085 Geopolitical Entities, Names, and Codes Terminology C16364 Brazil A country in eastern South America, bordering the Atlantic Ocean. C124085 Geopolitical Entities, Names, and Codes Terminology C16365 British Indian Ocean Territory An archipelago in the Indian Ocean, south of Africa, about one-half the way from Africa to Indonesia and south of the Maldives. C124085 Geopolitical Entities, Names, and Codes Terminology C16367 Brunei Darussalam A country in southeastern Asia, bordering the South China Sea and surrounded by Malaysia. C124085 Geopolitical Entities, Names, and Codes Terminology C16368 Bulgaria A country in southeastern Europe, bordering the Black Sea, between Romania and Turkey. C124085 Geopolitical Entities, Names, and Codes Terminology C16369 Burkina Faso A country in western Africa, between Mali and Ghana. C124085 Geopolitical Entities, Names, and Codes Terminology C16371 Burundi A country in central Africa, east of the Democratic Republic of the Congo and south of Rwanda. C124085 Geopolitical Entities, Names, and Codes Terminology C16378 Cambodia A country in southeastern Asia, bordering the Gulf of Thailand, between Thailand, Vietnam, and Laos. C124085 Geopolitical Entities, Names, and Codes Terminology C16379 Cameroon A country in western Africa, bordering the Gulf of Guinea, between Equatorial Guinea and Nigeria. C124085 Geopolitical Entities, Names, and Codes Terminology C16380 Canada A country in northern North America, bordering the North Atlantic Ocean on the east, North Pacific Ocean on the west, and the Arctic Ocean on the north, north of the conterminous US. C124085 Geopolitical Entities, Names, and Codes Terminology C16382 Cape Verde A group of islands in the North Atlantic Ocean, west of Senegal. C124085 Geopolitical Entities, Names, and Codes Terminology C16391 Cayman Islands An island group in the Caribbean Sea, south of Cuba and west of Jamaica. C124085 Geopolitical Entities, Names, and Codes Terminology C16409 Central African Republic A country in central Africa, north of Democratic Republic of the Congo, between Cameroon and South Sudan. C124085 Geopolitical Entities, Names, and Codes Terminology C16412 Chad A country in central Africa, south of Libya, between Niger and Sudan. C124085 Geopolitical Entities, Names, and Codes Terminology C16427 Chile A country in southwestern South America, bordering the South Pacific Ocean, between Argentina and Peru. C124085 Geopolitical Entities, Names, and Codes Terminology C16428 China A country in eastern Asia, bordering the East China Sea, Korea Bay, Yellow Sea, and South China Sea, south of Kazakhstan, Mongolia and Russia. C124085 Geopolitical Entities, Names, and Codes Terminology C44482 Christmas Island An Australian-administered island in the eastern Indian Ocean south of Java, Indonesia. C124085 Geopolitical Entities, Names, and Codes Terminology C123744 Clipperton Island An atoll in the North Pacific Ocean, southwest of Mexico. C124085 Geopolitical Entities, Names, and Codes Terminology C16445 Cocos (Keeling) Islands A group of islands in the Indian Ocean, south of Indonesia and west of Christmas Island. C124085 Geopolitical Entities, Names, and Codes Terminology C16449 Colombia A country in northern South America, bordering the Caribbean Sea and the North Pacific Ocean, between Ecuador and Venezuela. C124085 Geopolitical Entities, Names, and Codes Terminology C16458 Comoros A group of islands in the Mozambique Channel, about two-thirds of the way between northern Madagascar and northern Mozambique, northwest of Mayotte. C124085 Geopolitical Entities, Names, and Codes Terminology C16467 Congo A country in western Africa, bordering the South Atlantic Ocean, between Gabon and the Democratic Republic of the Congo. C124085 Geopolitical Entities, Names, and Codes Terminology C17266 Congo, the Democratic Republic of the A country in central Africa, northeast of Angola. C124085 Geopolitical Entities, Names, and Codes Terminology C16469 Cook Islands A group of islands in the South Pacific Ocean, east of Australia, between Tonga and French Polynesia. C124085 Geopolitical Entities, Names, and Codes Terminology C123745 Coral Sea Islands Numerous islands scattered over more than three-quarters of a million square kilometers of ocean that are a territory of Australia and located in Oceania, northeast of Austrualia. C124085 Geopolitical Entities, Names, and Codes Terminology C16470 Costa Rica A country in Central America, bordering both the Caribbean Sea and the North Pacific Ocean, between Nicaragua and Panama. C124085 Geopolitical Entities, Names, and Codes Terminology C16762 Cote d'Ivoire A country in western Africa, bordering the North Atlantic Ocean, between Ghana and Liberia. C124085 Geopolitical Entities, Names, and Codes Terminology C16474 Croatia A country in southeastern Europe, bordering the Adriatic Sea, between Bosnia and Herzegovina and Slovenia. C124085 Geopolitical Entities, Names, and Codes Terminology C16477 Cuba An island between the Caribbean Sea and the North Atlantic Ocean, 150 km south of Key West, Florida. C124085 Geopolitical Entities, Names, and Codes Terminology C101225 Curacao An island in the Caribbean Sea, north of Venezuela and east of Aruba, a constituent country of the Kingdom of the Netherlands. C124085 Geopolitical Entities, Names, and Codes Terminology C16480 Cyprus An island in the Mediterranean Sea, south of Turkey. C124085 Geopolitical Entities, Names, and Codes Terminology C17668 Czechia A country in central Europe, southeast of Germany and southwest of Poland. C124085 Geopolitical Entities, Names, and Codes Terminology C16496 Denmark A country in northern Europe, bordering the Baltic Sea and the North Sea, consisting of a peninsula on the north coast of Germany and several major islands. C124085 Geopolitical Entities, Names, and Codes Terminology C49345 Dhekelia A British Overseas Territory on the southeast coast of Cyprus. C124085 Geopolitical Entities, Names, and Codes Terminology C123746 Diego Garcia An atoll and the largest of 60 small islands comprising the Chagos Archipelago. C124085 Geopolitical Entities, Names, and Codes Terminology C16506 Djibouti A country in eastern Africa, bordering the Gulf of Aden and the Red Sea, between Eritrea and Somalia. C124085 Geopolitical Entities, Names, and Codes Terminology C16519 Dominica An island between the Caribbean Sea and the North Atlantic Ocean, south of Guadeloupe and north of Martinique. C124085 Geopolitical Entities, Names, and Codes Terminology C16520 Dominican Republic A country comprising the eastern two-thirds of the island of Hispaniola, between the Caribbean Sea and the North Atlantic Ocean, east of Haiti. C124085 Geopolitical Entities, Names, and Codes Terminology C16528 Ecuador A country in western South America, bordering the Pacific Ocean at the Equator, between Colombia and Peru. C124085 Geopolitical Entities, Names, and Codes Terminology C16530 Egypt A country in northern Africa, bordering the Mediterranean Sea, east of Libya and north of Sudan. C124085 Geopolitical Entities, Names, and Codes Terminology C16532 El Salvador A country in Central America, bordering the North Pacific Ocean, between Guatemala and Honduras. C124085 Geopolitical Entities, Names, and Codes Terminology C16557 Equatorial Guinea A country in western Africa, bordering the Gulf of Guinea, between Cameroon and Gabon; composed of a mainland portion and five inhabited islands. C124085 Geopolitical Entities, Names, and Codes Terminology C16558 Eritrea A country in eastern Africa, bordering the Red Sea, between Sudan and Ethiopia. C124085 Geopolitical Entities, Names, and Codes Terminology C16562 Estonia A country in eastern Europe, bordering the Baltic Sea and Gulf of Finland, between Latvia and Finland. C124085 Geopolitical Entities, Names, and Codes Terminology C16563 Ethiopia A country in eastern Africa, between Somalia and Sudan. C124085 Geopolitical Entities, Names, and Codes Terminology C123753 Europa Island An atoll in the Mozambique channel between southern Madagascar and southern Mozambique. C124085 Geopolitical Entities, Names, and Codes Terminology C17954 Falkland Islands (Malvinas) A group of islands in the South Atlantic Ocean, east of southern Argentina. C124085 Geopolitical Entities, Names, and Codes Terminology C16573 Faroe Islands An island group between the Norwegian Sea and the North Atlantic Ocean, about one-half of the way from Iceland to Norway. C124085 Geopolitical Entities, Names, and Codes Terminology C16582 Fiji A group of islands in the South Pacific Ocean, southwest of Wallis and Fortuna and east of Vanuatu. C124085 Geopolitical Entities, Names, and Codes Terminology C16584 Finland A country in northern Europe, bordering the Baltic Sea, between Sweden and Russia. C124085 Geopolitical Entities, Names, and Codes Terminology C16592 France A country in western Europe, bordering the Bay of Biscay and the English Channel, between Germany and Spain. C124085 Geopolitical Entities, Names, and Codes Terminology C16593 French Guiana A country in northern South America, bordering the North Atlantic Ocean, between Brazil and Suriname. C124085 Geopolitical Entities, Names, and Codes Terminology C16594 French Polynesia An archipelago in the South Pacific Ocean, east of the Cook Islands. C124085 Geopolitical Entities, Names, and Codes Terminology C20105 French Southern and Antarctic Lands A group of islands in the southern Indian Ocean, southeast of Africa, about equidistant between Africa, Antarctica, and Australia. C124085 Geopolitical Entities, Names, and Codes Terminology C123747 GENC Entity 1 A geopolitical entity designated by the Geopolitical Entities, Names, anc Codes Standard (GENC). C124085 Geopolitical Entities, Names, and Codes Terminology C123748 GENC Entity 2 A geopolitical entity designated by the Geopolitical Entities, Names, anc Codes Standard (GENC). C124085 Geopolitical Entities, Names, and Codes Terminology C123749 GENC Entity 3 A geopolitical entity designated by the Geopolitical Entities, Names, anc Codes Standard (GENC). C124085 Geopolitical Entities, Names, and Codes Terminology C123750 GENC Entity 4 A geopolitical entity designated by the Geopolitical Entities, Names, anc Codes Standard (GENC). C124085 Geopolitical Entities, Names, and Codes Terminology C123751 GENC Entity 5 A geopolitical entity designated by the Geopolitical Entities, Names, anc Codes Standard (GENC). C124085 Geopolitical Entities, Names, and Codes Terminology C123752 GENC Entity 6 A geopolitical entity designated by the Geopolitical Entities, Names, anc Codes Standard (GENC). C124085 Geopolitical Entities, Names, and Codes Terminology C16596 Gabon A country in central Africa, bordering the Atlantic Ocean at the Equator, between Republic of the Congo and Equatorial Guinea. C124085 Geopolitical Entities, Names, and Codes Terminology C123754 Gaza Strip 360 square kilometers in the Middle East, bordering the Mediterranean Sea, between Egypt and Israel. C124085 Geopolitical Entities, Names, and Codes Terminology C16634 Georgia (Republic) A country in southwestern Asia, bordering the Black Sea, between Turkey and Russia. C124085 Geopolitical Entities, Names, and Codes Terminology C16636 Germany A country in central Europe, bordering the Baltic Sea and the North Sea, between the Netherlands and Poland, south of Denmark. C124085 Geopolitical Entities, Names, and Codes Terminology C26330 Ghana A country in western Africa, bordering the Gulf of Guinea, between Cote d'Ivoire and Togo. C124085 Geopolitical Entities, Names, and Codes Terminology C16638 Gibraltar A dependency in southwestern Europe, on the southern coast of Spain, bordering the Strait of Gibraltar. C124085 Geopolitical Entities, Names, and Codes Terminology C123755 Glorioso Islands A group of French islands and rocks in the northern Mozambique channel, northwest of Madagascar. C124085 Geopolitical Entities, Names, and Codes Terminology C16645 Greece A country in southern Europe, bordering the Aegean, Ionian, and Mediterranean Seas, between Albania and Turkey. C124085 Geopolitical Entities, Names, and Codes Terminology C16646 Greenland An island between the Arctic Ocean and the North Atlantic Ocean, northeast of Canada. C124085 Geopolitical Entities, Names, and Codes Terminology C16647 Grenada An island between the Caribbean Sea and Atlantic Ocean, south of Saint Vincent and the Grenadines and north of Trinidad and Tobago. C124085 Geopolitical Entities, Names, and Codes Terminology C16651 Guadeloupe A group of islands in the Caribbean Seas, southeast of Montserrat. C124085 Geopolitical Entities, Names, and Codes Terminology C16652 Guam An island in the North Pacific Ocean, about three-quarters of the way from Hawaii to the Philippines, south of the Northern Mariana Islands. C124085 Geopolitical Entities, Names, and Codes Terminology C123756 Guantanamo Bay Naval Base A US Navy military base located on Guantanamo Bay in Cuba. C124085 Geopolitical Entities, Names, and Codes Terminology C16654 Guatemala A country in Central America, bordering the Caribbean Sea and the North Pacific Ocean, east of Mexico and west of Belize and Honduras. C124085 Geopolitical Entities, Names, and Codes Terminology C64375 Guernsey A British Crown dependency in the English Channel, between England and France. C124085 Geopolitical Entities, Names, and Codes Terminology C16655 Guinea A country in western Africa, bordering the North Atlantic Ocean, between Guinea-Bissau and Sierra Leone. C124085 Geopolitical Entities, Names, and Codes Terminology C16656 Guinea-Bissau A country in western Africa, bordering the North Atlantic Ocean, between Guinea and Senegal. C124085 Geopolitical Entities, Names, and Codes Terminology C16657 Guyana A country in northern South America, bordering the North Atlantic Ocean, between Suriname and Venezuela. C124085 Geopolitical Entities, Names, and Codes Terminology C16660 Haiti A country comprising the western one-third of the island of Hispaniola, between the Caribbean Sea and the North Atlantic Ocean, west of the Dominican Republic. C124085 Geopolitical Entities, Names, and Codes Terminology C20106 Heard Island and McDonald Islands A group of islands in the Indian Ocean, about two-thirds of the way from Madagascar to Antarctica, southeast of the French Southern and Antarctic Islands. C124085 Geopolitical Entities, Names, and Codes Terminology C17249 Holy See (Vatican City State) An enclave of Rome (Italy). C124085 Geopolitical Entities, Names, and Codes Terminology C16694 Honduras A country in Central America, bordering the Caribbean Sea, between Guatemala and Nicaragua. C124085 Geopolitical Entities, Names, and Codes Terminology C16695 Hong Kong A special administrative region of China, bordering the South China Sea, east of Macao. C124085 Geopolitical Entities, Names, and Codes Terminology C123759 Howland Island An island in the North Pacific Ocean, about halfway between Hawaii and Australia. C124085 Geopolitical Entities, Names, and Codes Terminology C16699 Hungary A country in central Europe, northwest of Romania and south of Slovakia. C124085 Geopolitical Entities, Names, and Codes Terminology C16704 Iceland A country in northern Europe, island between the Greenland Sea and the North Atlantic Ocean, northwest of the UK. C124085 Geopolitical Entities, Names, and Codes Terminology C16727 India A country in southern Asia, bordering the Arabian Sea and the Bay of Bengal, between Pakistan and China. C124085 Geopolitical Entities, Names, and Codes Terminology C16728 Indonesia A country in southeastern Asia, comprising the archipelago and islands between the Indian Ocean and the Pacific Ocean, north of Australia. C124085 Geopolitical Entities, Names, and Codes Terminology C16755 Iran, Islamic Republic of A country in the Middle East, bordering the Gulf of Oman, the Persian Gulf, and the Caspian Sea, between Iraq and Pakistan. C124085 Geopolitical Entities, Names, and Codes Terminology C16756 Iraq A country in the Middle East, bordering the Persian Gulf, between Iran and Syria. C124085 Geopolitical Entities, Names, and Codes Terminology C16757 Ireland A country in western Europe, occupying five-sixths of the island of Ireland in the North Atlantic Ocean, west of Great Britain. C124085 Geopolitical Entities, Names, and Codes Terminology C44480 Isle of Man An island in the Irish Sea, between Great Britain and Ireland. C124085 Geopolitical Entities, Names, and Codes Terminology C16760 Israel A country in the Middle East, bordering the Mediterranean Sea, between Egypt and Lebanon. C124085 Geopolitical Entities, Names, and Codes Terminology C16761 Italy A country in southern Europe, occupying a peninsula extending into the central Mediterranean Sea, northeast of Tunisia. C124085 Geopolitical Entities, Names, and Codes Terminology C16763 Jamaica An island in the Caribbean Sea, south of Cuba, between the Cayman Islands and Haiti. C124085 Geopolitical Entities, Names, and Codes Terminology C123760 Jan Mayen An island in Northern Europe, between the Greenland Sea and the Norwegian Sea. C124085 Geopolitical Entities, Names, and Codes Terminology C16764 Japan A country in eastern Asia, occupying an island chain between the North Pacific Ocean and the Sea of Japan, east of the Korean Peninsula. C124085 Geopolitical Entities, Names, and Codes Terminology C123761 Jarvis Island An island in the South Pacific Ocean between Hawaii and the Marshall Islands. C124085 Geopolitical Entities, Names, and Codes Terminology C64374 Jersey A British Crown dependency in the English Channel southeast of Guernsey. C124085 Geopolitical Entities, Names, and Codes Terminology C123762 Johnston Atoll An island in the North Pacific Ocean, between Hawaii and the Marshall Islands. C124085 Geopolitical Entities, Names, and Codes Terminology C16765 Jordan A country in the Middle East, northwest of Saudi Arabia. C124085 Geopolitical Entities, Names, and Codes Terminology C123763 Juan de Nova Island An island in the Mozambique Channel, between Madagascar and Mozambique. C124085 Geopolitical Entities, Names, and Codes Terminology C20107 Kazakhstan A country in central Asia, northwest of China and south of Russia. C124085 Geopolitical Entities, Names, and Codes Terminology C16769 Kenya A country in eastern Africa, bordering the Indian Ocean, between Somalia and Tanzania. C124085 Geopolitical Entities, Names, and Codes Terminology C123764 Kingman Reef A reef in the North Pacific Ocean, between Hawaii and American Samoa. C124085 Geopolitical Entities, Names, and Codes Terminology C16639 Kiribati A group of 33 coral atolls in the Pacific Ocean, south of Hawaii and northeast of Jarvis Island. C124085 Geopolitical Entities, Names, and Codes Terminology C16773 Korea, Democratic People's Republic of A country in eastern Asia, occupying the northern half of the Korean Peninsula, bordering the Korea Bay and the Sea of Japan, between China and South Korea. C124085 Geopolitical Entities, Names, and Codes Terminology C16774 Korea, Republic of A country in eastern Asia, occupying the southern half of the Korean Peninsula, bordering the Sea of Japan and the Yellow Sea. C124085 Geopolitical Entities, Names, and Codes Terminology C123740 Kosovo A southeastern European country between Servia and Macedonia. C124085 Geopolitical Entities, Names, and Codes Terminology C16775 Kuwait A country in the Middle East, bordering the Persian Gulf, between Iraq and Saudi Arabia. C124085 Geopolitical Entities, Names, and Codes Terminology C16771 Kyrgyzstan A country in central Asia, between southern Kazakhstan and western China. C124085 Geopolitical Entities, Names, and Codes Terminology C16780 Lao People's Democratic Republic A country in southeastern Asia, north and east of Thailand, west of Vietnam. C124085 Geopolitical Entities, Names, and Codes Terminology C16783 Latvia A country in eastern Europe, bordering the Baltic Sea, between Estonia and Lithuania. C124085 Geopolitical Entities, Names, and Codes Terminology C16784 Lebanon A country in the Middle East, bordering the Mediterranean Sea, between Israel and Syria. C124085 Geopolitical Entities, Names, and Codes Terminology C16787 Lesotho A country in southern Africa, an enclave of South Africa. C124085 Geopolitical Entities, Names, and Codes Terminology C16791 Liberia A country in western Africa, bordering the North Atlantic Ocean, between Cote d'Ivoire and Sierra Leone. C124085 Geopolitical Entities, Names, and Codes Terminology C16793 Libya A country in northern Africa, bordering the Mediterranean Sea, between Egypt and Algeria. C124085 Geopolitical Entities, Names, and Codes Terminology C16794 Liechtenstein A country in central Europe, between Austria and Switzerland. C124085 Geopolitical Entities, Names, and Codes Terminology C16799 Lithuania A country in eastern Europe, bordering the Baltic Sea, between Latvia and Russia. C124085 Geopolitical Entities, Names, and Codes Terminology C16803 Luxembourg A country in western Europe, between France, Belgium, and Germany. C124085 Geopolitical Entities, Names, and Codes Terminology C16807 Macau A special administrative region of China, bordering the South China Sea, west of Hong Kong. C124085 Geopolitical Entities, Names, and Codes Terminology C16808 Madagascar A country in southern Africa, occupying an island in the Indian Ocean, east of Mozambique. C124085 Geopolitical Entities, Names, and Codes Terminology C16813 Malawi A country in southern Africa, east of Zambia and west of Mozambique and Tanzania. C124085 Geopolitical Entities, Names, and Codes Terminology C16814 Malaysia A country in southeastern Asia bordering Indonesia and the South China Sea, occupying a peninsula south of Thailand and the northern one-third of the island of Borneo. C124085 Geopolitical Entities, Names, and Codes Terminology C16815 Maldives A country in southern Asia, occupying a group of atolls in the Indian Ocean, south-southwest of India and north of the British Indian Ocean Territory. C124085 Geopolitical Entities, Names, and Codes Terminology C16816 Mali A country in western Africa, southwest of Algeria and east of Mauritania. C124085 Geopolitical Entities, Names, and Codes Terminology C16817 Malta A country in southern Europe, occupying islands in the Mediterranean Sea, south of Sicily (Italy). C124085 Geopolitical Entities, Names, and Codes Terminology C16822 Marshall Islands A group of atolls and reefs in the North Pacific Ocean, about one-half of the way from Hawaii to Australia, south of Wake Island and north of Nauru. C124085 Geopolitical Entities, Names, and Codes Terminology C16823 Martinique An island between the Caribbean Sea and the North Atlantic Ocean, south of Dominica and north of Saint Lucia. C124085 Geopolitical Entities, Names, and Codes Terminology C16826 Mauritania A country in northern Africa, bordering the North Atlantic Ocean, between Senegal, Western Sahara, and Mali. C124085 Geopolitical Entities, Names, and Codes Terminology C16827 Mauritius A country in southern Africa, occupying an island in the Indian Ocean, off the coast of Madagascar, east of Reunion. C124085 Geopolitical Entities, Names, and Codes Terminology C16828 Mayotte A country in southern Africa, occupying an island in the Mozambique Channel, about one-half of the way from northern Madagascar to northern Mozambique, southeast of Comoros. C124085 Geopolitical Entities, Names, and Codes Terminology C16850 Mexico A country in southern North America, bordering the North Pacific Ocean and the Gulf of Mexico, south of the US. C124085 Geopolitical Entities, Names, and Codes Terminology C17881 Micronesia, Federated States of An island group in the North Pacific Ocean, about three-quarters of the way from Hawaii to Indonesia, west of the Marshall Islands and north of the Solomon Islands. C124085 Geopolitical Entities, Names, and Codes Terminology C110919 Midway Islands, UM An atoll in the North Pacific Ocean near the end of the Hawaiian Archipelago. C124085 Geopolitical Entities, Names, and Codes Terminology C16871 Moldova, Republic of A country in eastern Europe, northeast of Romania. C124085 Geopolitical Entities, Names, and Codes Terminology C16874 Monaco A country in western Europe, bordering the Mediterranean Sea on the southern coast of France, near the border with Italy. C124085 Geopolitical Entities, Names, and Codes Terminology C16875 Mongolia A country in northern Asia, between China and Russia. C124085 Geopolitical Entities, Names, and Codes Terminology C64378 Montenegro A country in southeastern Europe, bordering the Adriatic Sea, between Albania and Bosnia and Herzegovina. C124085 Geopolitical Entities, Names, and Codes Terminology C16876 Montserrat An island in the Caribbean Seas, southeast of Saint Kitts and Nevis. C124085 Geopolitical Entities, Names, and Codes Terminology C16878 Morocco A country in northern Africa, bordering the North Atlantic Ocean and the Mediterranean Sea, south of Spain and between Algeria and Western Sahara. C124085 Geopolitical Entities, Names, and Codes Terminology C16882 Mozambique A country in southeastern Africa, bordering the Mozambique Channel, between South Africa and Tanzania. C124085 Geopolitical Entities, Names, and Codes Terminology C16370 Myanmar A country in southeastern Asia, bordering the Andaman Sea and the Bay of Bengal, southwest of China, between Bangladesh and Thailand. C124085 Geopolitical Entities, Names, and Codes Terminology C16891 Namibia A country in southwestern Africa, bordering the South Atlantic Ocean, between Angola and South Africa. C124085 Geopolitical Entities, Names, and Codes Terminology C16896 Nauru A country in Oceania, occupying an island in the South Pacific Ocean, south of the Marshall Islands. C124085 Geopolitical Entities, Names, and Codes Terminology C123766 Navassa Island An island in the Caribbean Sea that is west of Haiti. C124085 Geopolitical Entities, Names, and Codes Terminology C16901 Nepal A country in southern Asia, between China and India, west of Bhutan. C124085 Geopolitical Entities, Names, and Codes Terminology C16903 Netherlands A country in western Europe, bordering the North Sea, between Belgium and Germany. C124085 Geopolitical Entities, Names, and Codes Terminology C16913 New Caledonia A country in the Pacific, comprised of islands in the South Pacific Ocean, east of Australia. C124085 Geopolitical Entities, Names, and Codes Terminology C16914 New Zealand A country in the Pacific, comprised of islands in the South Pacific Ocean, southeast of Australia. C124085 Geopolitical Entities, Names, and Codes Terminology C16915 Nicaragua A country in Central America, bordering both the Caribbean Sea and the North Pacific Ocean, between Costa Rica and Honduras. C124085 Geopolitical Entities, Names, and Codes Terminology C16916 Niger A country in western Africa, southeast of Algeria and north of Nigeria. C124085 Geopolitical Entities, Names, and Codes Terminology C16917 Nigeria A country in western Africa, bordering the Gulf of Guinea, between Benin and Cameroon. C124085 Geopolitical Entities, Names, and Codes Terminology C16918 Niue A country in the Pacific, occupying an island in the South Pacific Ocean, east of Tonga and south of American Samoa. C124085 Geopolitical Entities, Names, and Codes Terminology C16919 Norfolk Island A country in the Pacific, occupying an island in the South Pacific Ocean, east of Australia and between New Caledonia and New Zealand. C124085 Geopolitical Entities, Names, and Codes Terminology C17654 North Macedonia A country in southeastern Europe, north of Greece, between Albania and Bulgaria. C124085 Geopolitical Entities, Names, and Codes Terminology C17882 Northern Mariana Islands A country in the Pacific, comprising islands in the North Pacific Ocean, about three-quarters of the way from Hawaii to the Philippines, north of Guam. C124085 Geopolitical Entities, Names, and Codes Terminology C16920 Norway A country in northern Europe, bordering the North Sea and the North Atlantic Ocean, west of Sweden. C124085 Geopolitical Entities, Names, and Codes Terminology C16933 Oman A country in the Middle East, bordering the Arabian Sea, southeast of Saudi Arabia. C124085 Geopolitical Entities, Names, and Codes Terminology C16949 Pakistan A country in southern Asia, bordering the Arabian Sea, between India on the east and Iran and Afghanistan on the west and China in the north. C124085 Geopolitical Entities, Names, and Codes Terminology C17733 Palau A country in the Pacific, comprising a group of islands in the North Pacific Ocean, southeast of the Philippines and northwest of Papua New Guinea. C124085 Geopolitical Entities, Names, and Codes Terminology C123767 Palmyra Atoll An atoll in the North Pacific Ocean halfway between Hawaii and American Samoa. C124085 Geopolitical Entities, Names, and Codes Terminology C16951 Panama A country in Central America, bordering both the Caribbean Sea and the North Pacific Ocean, between Colombia and Costa Rica. C124085 Geopolitical Entities, Names, and Codes Terminology C16952 Papua New Guinea A country in southeastern Asia, comprising a group of islands and including the eastern half of the island of New Guinea, between the Coral Sea and the South Pacific Ocean, east of Indonesia. C124085 Geopolitical Entities, Names, and Codes Terminology C123768 Paracel Islands A group of small islands and reefs in the South China Sea, between Vietnam and the Philippines. C124085 Geopolitical Entities, Names, and Codes Terminology C16953 Paraguay A country in central South America, northeast of Argentina. C124085 Geopolitical Entities, Names, and Codes Terminology C16972 Peru A country in western South America, bordering the South Pacific Ocean, between Chile and Ecuador. C124085 Geopolitical Entities, Names, and Codes Terminology C16978 Philippines A country in southeastern Asia, comprised of an archipelago between the Philippine Sea and the South China Sea, east of Vietnam. C124085 Geopolitical Entities, Names, and Codes Terminology C16993 Pitcairn A country in the Pacific, comprised of islands in the South Pacific Ocean, about midway between Peru and New Zealand, southeast of French Polynesia. C124085 Geopolitical Entities, Names, and Codes Terminology C17002 Poland A country in central Europe, east of Germany. C124085 Geopolitical Entities, Names, and Codes Terminology C17006 Portugal A country in southwestern Europe, bordering the North Atlantic Ocean, west of Spain. C124085 Geopolitical Entities, Names, and Codes Terminology C17043 Puerto Rico An island between the Caribbean Sea and the North Atlantic Ocean, east of the Dominican Republic and west of the British Virgin Islands. C124085 Geopolitical Entities, Names, and Codes Terminology C17045 Qatar A country in the Middle East, occupying a peninsula bordering the Persian Gulf and Saudi Arabia. C124085 Geopolitical Entities, Names, and Codes Terminology C17095 Reunion A country in southern Africa, occupying an island in the Indian Ocean, east of Madagascar and west of Mauritius. C124085 Geopolitical Entities, Names, and Codes Terminology C17108 Romania A country in southeastern Europe, bordering the Black Sea, between Bulgaria and Ukraine. C124085 Geopolitical Entities, Names, and Codes Terminology C17111 Russian Federation A country in northern Asia, bordering the Arctic Ocean, between Europe and the North Pacific Ocean. C124085 Geopolitical Entities, Names, and Codes Terminology C17112 Rwanda A country in central Africa, between the Democratic Republic of the Congo and Tanzania and north of Burundi. C124085 Geopolitical Entities, Names, and Codes Terminology C83609 Saint Barthelemy An island in the Caribbean sea, southeast of Anguilla and north of Saint Kitts and Nevis. C124085 Geopolitical Entities, Names, and Codes Terminology C17164 Saint Helena, Ascension and Tristan da Cunha A group of islands in the South Atlantic Ocean, about midway between South America and Africa, west of Angola and South Africa. C124085 Geopolitical Entities, Names, and Codes Terminology C17885 Saint Kitts and Nevis A group of islands in the Caribbean Sea, east of the Virgin Islands and south of Anguilla. C124085 Geopolitical Entities, Names, and Codes Terminology C17113 Saint Lucia An island between the Caribbean Sea and the North Atlantic Ocean, south of Martinique and north of Saint Vincent and the Grenadines. C124085 Geopolitical Entities, Names, and Codes Terminology C83610 Saint Martin (French Part) A country comprising the northern portion of an island in the Caribbean sea, between Anguilla and Saint Barthelemy. C124085 Geopolitical Entities, Names, and Codes Terminology C17165 Saint Pierre and Miquelon A country in northern North America, comprised of islands in the North Atlantic Ocean, south of Newfoundland (Canada). C124085 Geopolitical Entities, Names, and Codes Terminology C17114 Saint Vincent and the Grenadines A group of islands between the Caribbean Sea and the North Atlantic Ocean, south of Saint Lucia and north of Granada. C124085 Geopolitical Entities, Names, and Codes Terminology C17740 Samoa A group of islands in the South Pacific Ocean, about half way from Hawaii to New Zealand, west of American Samoa. C124085 Geopolitical Entities, Names, and Codes Terminology C17115 San Marino A country in southern Europe, an enclave in central Italy. C124085 Geopolitical Entities, Names, and Codes Terminology C17116 Sao Tome and Principe A country in western Africa, comprised of islands in the Gulf of Guinea, straddling the Equator, west of Gabon. C124085 Geopolitical Entities, Names, and Codes Terminology C17117 Saudi Arabia A country in the Middle East, bordering the Persian Gulf and the Red Sea, north of Yemen. C124085 Geopolitical Entities, Names, and Codes Terminology C17121 Senegal A country in western Africa, bordering the North Atlantic Ocean, between Guinea-Bissau and Mauritania. C124085 Geopolitical Entities, Names, and Codes Terminology C64377 Serbia A republic in southeastern Europe, between Romania and Bosnia and Herzegovina. C124085 Geopolitical Entities, Names, and Codes Terminology C17129 Seychelles A country in eastern Africa, comprised of a group of islands in the Indian Ocean, northeast of Madagascar and east of Kenya. C124085 Geopolitical Entities, Names, and Codes Terminology C17130 Sierra Leone A country in western Africa, bordering the North Atlantic Ocean, between Guinea and Liberia. C124085 Geopolitical Entities, Names, and Codes Terminology C17134 Singapore A country in southeastern Asia, comprised of the southern tip of the Malaysian peninsula and nearby islands between Malaysia and Indonesia. C124085 Geopolitical Entities, Names, and Codes Terminology C101226 Sint Maarten (Dutch Part) A country comprising the southern portion of an island in the Caribbean sea, between Anguilla and Saint Barthelemy, a constituent country of the Kingdom of the Netherlands. C124085 Geopolitical Entities, Names, and Codes Terminology C17669 Slovakia A country in central Europe, south of Poland and north of Hungary. C124085 Geopolitical Entities, Names, and Codes Terminology C17138 Slovenia A country in central Europe, bordering the Adriatic Sea, between Austria and Croatia. C124085 Geopolitical Entities, Names, and Codes Terminology C17148 Solomon Islands A group of islands in the South Pacific Ocean, east of Papua New Guinea. C124085 Geopolitical Entities, Names, and Codes Terminology C17149 Somalia A country in eastern Africa, bordering the Gulf of Aden and the Indian Ocean, east of Ethiopia. C124085 Geopolitical Entities, Names, and Codes Terminology C17151 South Africa A country in southern Africa, at the southern tip of the continent of Africa. C124085 Geopolitical Entities, Names, and Codes Terminology C20111 South Georgia and the South Sandwich Islands A group of islands in the South Atlantic Ocean, east of the Falkland Islands. C124085 Geopolitical Entities, Names, and Codes Terminology C97351 South Sudan A country in east central Africa south of Sudan, north of Uganda and Kenya, and west of Ethiopia. C124085 Geopolitical Entities, Names, and Codes Terminology C17152 Spain A country in southwestern Europe, bordering the Bay of Biscay, Mediterranean Sea, and North Atlantic Ocean, southwest of France. C124085 Geopolitical Entities, Names, and Codes Terminology C123769 Spratly Islands More than 100 small islands in the South China Sea, between southern Vietnam and the southern Philippines. C124085 Geopolitical Entities, Names, and Codes Terminology C17163 Sri Lanka A country in southern Asia, occupying an island in the Indian Ocean, southeast of India. C124085 Geopolitical Entities, Names, and Codes Terminology C17170 Sudan A country in northeastern Africa, bordering the Red Sea, between Egypt and Eritrea. C124085 Geopolitical Entities, Names, and Codes Terminology C17175 Suriname A country in northern South America, bordering the North Atlantic Ocean, between French Guiana and Guyana. C124085 Geopolitical Entities, Names, and Codes Terminology C123770 Svalbard Islands in the Artic Ocean, between Norway and the North Pole. C124085 Geopolitical Entities, Names, and Codes Terminology C17179 Swaziland A country in southern Africa, between Mozambique and South Africa. C124085 Geopolitical Entities, Names, and Codes Terminology C17180 Sweden A country in northern Europe, bordering the Baltic Sea, between Finland and Norway. C124085 Geopolitical Entities, Names, and Codes Terminology C17181 Switzerland A country in central Europe, east of France and north of Italy. C124085 Geopolitical Entities, Names, and Codes Terminology C17182 Syrian Arab Republic A country in the Middle East, bordering the Mediterranean Sea, between Lebanon and Turkey. C124085 Geopolitical Entities, Names, and Codes Terminology C17184 Taiwan A group of islands bordering the East China Sea, Philippine Sea, South China Sea, and Taiwan Strait, off the southeastern coast of China north of the Philippines. C124085 Geopolitical Entities, Names, and Codes Terminology C17183 Tajikistan A country in central Asia, south of Kyrgyzstan and west of China. C124085 Geopolitical Entities, Names, and Codes Terminology C17185 Tanzania, United Republic of A country in eastern Africa, bordering the Indian Ocean, between Kenya and Mozambique. C124085 Geopolitical Entities, Names, and Codes Terminology C17192 Thailand A country in southeastern Asia, bordering the Andaman Sea and the Gulf of Thailand, southeast of Burma. C124085 Geopolitical Entities, Names, and Codes Terminology C16598 The Gambia A country in western Africa, bordering the North Atlantic Ocean and surrounded by Senegal. C124085 Geopolitical Entities, Names, and Codes Terminology C17200 Timor-Leste A country in southeastern Asia, northwest of Australia in the Lesser Sunda Islands at the eastern end of the Indonesian archipelago. East Timor includes the eastern half of the island of Timor, the Oecussi (Ambeno) region on the northwest portion of the island of Timor, and the islands of Pulau Atauro and Pulau Jaco. C124085 Geopolitical Entities, Names, and Codes Terminology C17202 Togo A country in western Africa, bordering the Gulf of Guinea, between Benin and Ghana. C124085 Geopolitical Entities, Names, and Codes Terminology C17704 Tokelau A group of three atolls in the South Pacific Ocean, about one-half of the way from Hawaii to New Zealand, west of Tuvalu and north of American Samoa. C124085 Geopolitical Entities, Names, and Codes Terminology C17205 Tonga An archipelago in the South Pacific Ocean, about two-thirds of the way from Hawaii to New Zealand, southeast of Fiji. C124085 Geopolitical Entities, Names, and Codes Terminology C17217 Trinidad and Tobago A group of islands between the Caribbean Sea and the North Atlantic Ocean, off the northeast coast of Venezuela. C124085 Geopolitical Entities, Names, and Codes Terminology C123771 Tromelin Island An island in the Indian Ocean east of Madagascar. C124085 Geopolitical Entities, Names, and Codes Terminology C17221 Tunisia A country in northern Africa, bordering the Mediterranean Sea, between Algeria and Libya. C124085 Geopolitical Entities, Names, and Codes Terminology C17222 Turkey A country in southeastern Europe and southwestern Asia, between the Black Sea and Mediterranean Sea, east of Greece and north of Syria. C124085 Geopolitical Entities, Names, and Codes Terminology C17223 Turkmenistan A country in central Asia, bordering the Caspian Sea, between Iran and Kazakhstan. C124085 Geopolitical Entities, Names, and Codes Terminology C17224 Turks and Caicos Islands Two island groups in the North Atlantic Ocean, southeast of The Bahamas and north of Haiti. C124085 Geopolitical Entities, Names, and Codes Terminology C17225 Tuvalu A group of islands consisting of nine coral atolls in the South Pacific Ocean, about one-half of the way from Hawaii to Australia, west of Tokelau and north of Fiji. C124085 Geopolitical Entities, Names, and Codes Terminology C17228 Uganda A country in eastern Africa, west of Kenya. C124085 Geopolitical Entities, Names, and Codes Terminology C17229 Ukraine A country in eastern Europe, bordering the Black Sea, between Poland and Russia. C124085 Geopolitical Entities, Names, and Codes Terminology C17232 United Arab Emirates A country in the Middle East, bordering the Gulf of Oman and the Persian Gulf, between Oman and Saudi Arabia. C124085 Geopolitical Entities, Names, and Codes Terminology C17233 United Kingdom A country in western Europe, comprising islands, including England, Scotland, Wales, and the northern one-sixth of the island of Ireland, between the North Atlantic Ocean and the North Sea, northwest of France. C124085 Geopolitical Entities, Names, and Codes Terminology C17234 United States A country in North America, between Canada and Mexico, bordering both the North Atlantic Ocean and the North Pacific Ocean. C124085 Geopolitical Entities, Names, and Codes Terminology C123772 Unknown GENC Values reserved for a geopolitical name of Unknown by the Geopolitical entities, names and codes (GENC) standard. C124085 Geopolitical Entities, Names, and Codes Terminology C17244 Uruguay A country in southern South America, bordering the South Atlantic Ocean, between Argentina and Brazil. C124085 Geopolitical Entities, Names, and Codes Terminology C17246 Uzbekistan A country in central Asia, north of Afghanistan, between Turkmenistan and Kazakhstan. C124085 Geopolitical Entities, Names, and Codes Terminology C17247 Vanuatu A group of islands in the South Pacific Ocean, about three-quarters of the way from Hawaii to Australia. C124085 Geopolitical Entities, Names, and Codes Terminology C17250 Venezuela, Bolivarian Republic of A country in northern South America, bordering the Caribbean Sea and the North Atlantic Ocean, between Colombia and Guyana. C124085 Geopolitical Entities, Names, and Codes Terminology C17252 Viet Nam A country in southeastern Asia, bordering the Gulf of Thailand, Gulf of Tonkin, and South China Sea, alongside China, Laos, and Cambodia. C124085 Geopolitical Entities, Names, and Codes Terminology C17653 Virgin Islands, British A group of islands between the Caribbean Sea and the North Atlantic Ocean, east of the US Virgin Islands. C124085 Geopolitical Entities, Names, and Codes Terminology C17255 Virgin Islands, U.S. A group of islands between the Caribbean Sea and the North Atlantic Ocean, east of Puerto Rico and west of the British Virgin Islands. C124085 Geopolitical Entities, Names, and Codes Terminology C123773 Wake Island An atoll in the North Pacific Ocean, between Hawaii and the Northern Mariana Islands. C124085 Geopolitical Entities, Names, and Codes Terminology C17259 Wallis and Futuna A group of islands in the South Pacific Ocean, about two-thirds of the way from Hawaii to New Zealand, northeast of Fiji and west of American Samoa. C124085 Geopolitical Entities, Names, and Codes Terminology C123774 West Bank 5860 square kilometers in the Middle east that is west of Jordan and east of Israel. C124085 Geopolitical Entities, Names, and Codes Terminology C20113 Western Sahara A country in northern Africa, bordering the North Atlantic Ocean, between Mauritania and Morocco. C124085 Geopolitical Entities, Names, and Codes Terminology C17264 Yemen A country in the Middle East, bordering the Arabian Sea, Gulf of Aden, and Red Sea, between Oman and Saudi Arabia. C124085 Geopolitical Entities, Names, and Codes Terminology C17267 Zambia A country in southern Africa, east of Angola and north of Zimbabwe. C124085 Geopolitical Entities, Names, and Codes Terminology C17268 Zimbabwe A country in southern Africa, between South Africa and Zambia, west of Mozambique. C168639 PQ/CMC Application Type Terminology C115123 Abbreviated New Animal Drug Application Data submitted to an abbreviated new animal drug application. Abbreviated New Animal Drug Application PQCMC data submitted to an abbreviated (generic) new animal drug application. C168639 PQ/CMC Application Type Terminology C73113 Abbreviated New Drug Application Data submitted to an abbreviated new drug application. Abbreviated New Drug Application PQCMC data submitted to an abbreviated (generic) new human drug application. C168639 PQ/CMC Application Type Terminology C71778 Biologics License Application A formal submission to FDA from any legal person or entity to obtain permission for manufacturing and marketing a biological product subject to licensure under section 351 of the Public Health Service Act. A biologics license application must contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product, sufficient for the FDA to determine that the establishment and the product meet applicable requirements to ensure the continued safety, purity, and potency of the product, including but not limited to GMPs. Biologics License Application PQCMC data submitted to a biologics license application. C168639 PQ/CMC Application Type Terminology C115122 Generic Investigational New Animal Drug File Data submitted to a generic investigational new animal drug file. Generic Investigational New Animal Drug File PQCMC data submitted to a generic investigational new animal drug file. C168639 PQ/CMC Application Type Terminology C80440 Humanitarian Device Exemption A premarket submission to FDA for a device intended to benefit patients by treating or diagnosing a condition affecting fewer than 4,000 individuals in the United States per year. An HDE is similar in form and content to a premarket approval (PMA) but is exempt from the effectiveness requirements of a PMA. Humanitarian Device Exemption (HDE) PQCMC data submitted for an HDE application. C168639 PQ/CMC Application Type Terminology C82667 Investigational Device Exemption Allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval application or a Premarket Notification submission to the Food and Drug Administration. Investigational Device Exemption PQCMC data submitted to an investigational device exemption. C168639 PQ/CMC Application Type Terminology C96091 Investigational New Animal Drug File Data submitted to an investigational new animal drug file. Investigational New Animal Drug File PQCMC data submitted to an investigational new animal drug file. C168639 PQ/CMC Application Type Terminology C96090 Investigational New Drug Application Data submitted to an investigational new human drug application. Investigational New Drug Application PQCMC data submitted to an investigational new human drug application. C168639 PQ/CMC Application Type Terminology C96092 New Active Ingredient Data submitted for an active ingredient. New Active Ingredient PQCMC data submitted for an active ingredient, could be PQCMC data for an active ingredient submitted in a drug application, or a Master File. C168639 PQ/CMC Application Type Terminology C72901 New Animal Drug Application Data submitted to a new animal drug application. New Animal Drug Application PQCMC data submitted to a new animal drug application. C168639 PQ/CMC Application Type Terminology C72899 New Drug Application A regulatory document submitted to the FDA proposing the approval of a new drug to be marketed and sold in the U.S. It includes supporting data from both animal and human studies that was initially provided in the Investigational New Drug application (IND). New Drug Application PQCMC data submitted to a new human drug application. C168639 PQ/CMC Application Type Terminology C70880 Pre-market Approval Application An application to FDA for a license to market a new device in the United States. Premarket Approval PQCMC data submitted for a PMA application. C168639 PQ/CMC Application Type Terminology C80442 Premarket Device Notification A premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective as a legally marketed device that is not subject to PMA (Premarket Authorization). Premarket Notification 510(K) PQCMC data submitted for a premarket 510(k) submission. C133851 PQ/CMC Conformance to Criteria Terminology C80262 Conformance Correspondence in form or appearance. Conforms Correspondence in form or appearance. C133851 PQ/CMC Conformance to Criteria Terminology C133998 Does Not Conform An observation that the item of interest does not match required specifications. Does not conform An observation that the item of interest does not match required specifications. C133858 PQ/CMC Interpretation Code Terminology C48793 Equivalent A person or thing equal to another in value or measure or force or effect or significance etc; being essentially equal to something. EQ C133858 PQ/CMC Interpretation Code Terminology C61584 Greater Than A statement about the relative size or order of two objects specifying that an object of interest exceeds another object in quantity or measure or value or status. MT (more than) A statement about the relative size or order of two objects specifying that an object of interest exceeds another object in quantity or measure or value or status. C133858 PQ/CMC Interpretation Code Terminology C61583 Greater Than or Equal To A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest exceeds the other object in one of these ways. NLT (not less than) A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest exceeds the other object in one of these ways. C133858 PQ/CMC Interpretation Code Terminology C61585 Less Than A statement about the relative size or order of two objects specifying that an object of interest is smaller than another object in quantity or measure or value or status. LT (less than) A statement about the relative size or order of two objects specifying that an object of interest is smaller than another object in quantity or measure or value or status. C133858 PQ/CMC Interpretation Code Terminology C61586 Less Than or Equal To A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest is smaller than the other object in one of these ways. NMT (not more than) A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest is smaller than the other object in one of these ways. C133858 PQ/CMC Interpretation Code Terminology C48660 Not Applicable Determination of a value is not relevant in the current context. Not Applicable NA Determination of a value is not relevant in the current context. C133859 PQ/CMC Manufacturing Site Unique Identifier Type Terminology C134005 Central File Number A seven digit number assigned by the Food and Drug Administration (FDA). CFN A seven digit number assigned by the Food and Drug Administration (FDA). C133859 PQ/CMC Manufacturing Site Unique Identifier Type Terminology C134003 Data Universal Numbering System A proprietary system developed and regulated by Dun & Bradstreet that assigns a unique nine digit numeric identifier to a single business entity location. DUNS A proprietary system developed and regulated by Dun & Bradstreet that assigns a unique nine digit numeric identifier to a single business entity location. C133859 PQ/CMC Manufacturing Site Unique Identifier Type Terminology C134004 Facility FDA Establishment Identifier A unique identifier assigned by the Food and Drug Administration (FDA) to track inspections of a regulated establishment or facility. They are also used to track generic drug user fee acts (GDUFA) facility fee payments. FEI A unique identifier assigned by the Food and Drug Administration (FDA) to track inspections of a regulated establishment or facility. They are also used to track generic drug user fee acts (GDUFA) facility fee payments. C133859 PQ/CMC Manufacturing Site Unique Identifier Type Terminology C17998 Unknown Not known, not observed, not recorded, or refused. Unknown Not known, not observed, not recorded, or refused. C133862 PQ/CMC Source Type Terminology C14182 Animal A living organism that has membranous cell walls, requires oxygen and organic foods, and is capable of voluntary movement, as distinguished from a plant or mineral. Animal A living organism that has membranous cell walls, requires oxygen and organic foods, and is capable of voluntary movement, as distinguished from a plant or mineral. C133862 PQ/CMC Source Type Terminology C18634 Animal Sources Indicates that a product is derived from an animal. Animal-derived indirectly Indicates that a product is derived from an animal. C133862 PQ/CMC Source Type Terminology C48807 Chemical A substance with a defined atomic or molecular structure that results from, or takes part in, reactions involving changes in its structure, composition, or properties. Chemical A substance with a defined atomic or molecular structure that results from, or takes part in, reactions involving changes in its structure, composition, or properties. C133862 PQ/CMC Source Type Terminology C14225 Human The bipedal primate mammal, Homo sapiens; belonging to man or mankind; pertaining to man or to the race of man; use of man as experimental subject or unit of analysis in research. Human The bipedal primate mammal, Homo sapiens; belonging to man or mankind; pertaining to man or to the race of man; use of man as experimental subject or unit of analysis in research. C133862 PQ/CMC Source Type Terminology C14227 Insect A taxonomic class of arthropods that includes praying mantises, dragonflies, grasshoppers, true bugs, flies, bees, wasps, ants, butterflies, moths, and beetles. Insect A taxonomic class of arthropods that includes praying mantises, dragonflies, grasshoppers, true bugs, flies, bees, wasps, ants, butterflies, moths, and beetles. C133862 PQ/CMC Source Type Terminology C14329 Microorganism A microscopic organism. The term microorganism may refer to a prokaryote or eukaryote, and may be a unicellular or multicellular organism. All taxonomic kingdoms contain microorganisms. Microbial A microscopic organism. The term microorganism may refer to a prokaryote or eukaryote, and may be a unicellular or multicellular organism. All taxonomic kingdoms contain microorganisms. C133862 PQ/CMC Source Type Terminology C14258 Plant Any living organism that typically synthesizes its food from inorganic substances, possesses cellulose cell walls, responds slowly and often permanently to a stimulus, lacks specialized sense organs and nervous system, and has no powers of locomotion. (EPA Terminology Reference System) Plant Any living organism that typically synthesizes its food from inorganic substances, possesses cellulose cell walls, responds slowly and often permanently to a stimulus, lacks specialized sense organs and nervous system, and has no powers of locomotion. (EPA Terminology Reference System) C133863 PQ/CMC Specification Status Terminology C25425 Approval Acceptance as satisfactory by an authoritative body; established by authority; given authoritative approval. Approved Acceptance as satisfactory by an authoritative body; established by authority; given authoritative approval. C133863 PQ/CMC Specification Status Terminology C48660 Not Applicable Determination of a value is not relevant in the current context. Not Applicable NA Determination of a value is not relevant in the current context. C133863 PQ/CMC Specification Status Terminology C134011 Not Approved A specification that has not yet been approved. Not Approved A specification that has not yet been approved. C133863 PQ/CMC Specification Status Terminology C134012 Reported in a CBE or AR The specification may be used without prior approval, and was submitted in a changes being effected (CBE) supplement or an annual report (AR). Reported in a CBE or AR The specification may be used without prior approval, and was submitted in a changes being effected (CBE) supplement or an annual report (AR). C133863 PQ/CMC Specification Status Terminology C134010 Tentative Approval Provisional approval of a specification. Tentatively Approved Provisional approval of a specification. C133864 PQ/CMC Specification Type Terminology C134021 Drug Product Specification The specification which is applied to the drug product. Drug Product The specification which is applied to the drug product. C133864 PQ/CMC Specification Type Terminology C134022 Drug Substance Specification The specification which is applied to the drug substance. Drug Substance The specification which is applied to the drug substance. C133864 PQ/CMC Specification Type Terminology C133931 Raw Materials/Excipients/Intermediates/Reagents Specification The specification which is applied to the raw materials, excipients, intermediates or reagents. Raw Materials/Excipients/Intermediates/Reagents The specification which is applied to the raw materials, excipients, intermediates or reagents. C168624 PQ/CMC Sponsor Identifier Type Terminology C134005 Central File Number A seven digit number assigned by the Food and Drug Administration (FDA). CFN A seven digit number assigned by the Food and Drug Administration (FDA). C168624 PQ/CMC Sponsor Identifier Type Terminology C134003 Data Universal Numbering System A proprietary system developed and regulated by Dun & Bradstreet that assigns a unique nine digit numeric identifier to a single business entity location. DUNS A proprietary system developed and regulated by Dun & Bradstreet that assigns a unique nine digit numeric identifier to a single business entity location. C168624 PQ/CMC Sponsor Identifier Type Terminology C134004 Facility FDA Establishment Identifier A unique identifier assigned by the Food and Drug Administration (FDA) to track inspections of a regulated establishment or facility. They are also used to track generic drug user fee acts (GDUFA) facility fee payments. FEI A unique identifier assigned by the Food and Drug Administration (FDA) to track inspections of a regulated establishment or facility. They are also used to track generic drug user fee acts (GDUFA) facility fee payments. C168624 PQ/CMC Sponsor Identifier Type Terminology C17998 Unknown Not known, not observed, not recorded, or refused. Unknown Not known, not observed, not recorded, or refused. C168622 PQ/CMC Strength Operator Terminology C48793 Equivalent A person or thing equal to another in value or measure or force or effect or significance etc; being essentially equal to something. EQ C168622 PQ/CMC Strength Operator Terminology C61584 Greater Than A statement about the relative size or order of two objects specifying that an object of interest exceeds another object in quantity or measure or value or status. MT (more than) A statement about the relative size or order of two objects specifying that an object of interest exceeds another object in quantity or measure or value or status. C168622 PQ/CMC Strength Operator Terminology C61583 Greater Than or Equal To A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest exceeds the other object in one of these ways. NLT (not less than) A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest exceeds the other object in one of these ways. C168622 PQ/CMC Strength Operator Terminology C61585 Less Than A statement about the relative size or order of two objects specifying that an object of interest is smaller than another object in quantity or measure or value or status. LT (less than) A statement about the relative size or order of two objects specifying that an object of interest is smaller than another object in quantity or measure or value or status. C168622 PQ/CMC Strength Operator Terminology C61586 Less Than or Equal To A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest is smaller than the other object in one of these ways. NMT (not more than) A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest is smaller than the other object in one of these ways. C168622 PQ/CMC Strength Operator Terminology C48660 Not Applicable Determination of a value is not relevant in the current context. Not Applicable NA Determination of a value is not relevant in the current context. C168627 PQ/CMC Strength Type Terminology C45420 Biochemical Activity A measurable amount of a specific function or role performed by a entity in a biophysical process, biochemical reaction, or biochemical process. Activity A measure of a property related to therapeutic or biological effect. Example, enzyme activity. C168627 PQ/CMC Strength Type Terminology C168628 Drug Component Mass The mass of the active and inactive substances in a drug component. Mass The amount of active and/or inactive substance of a drug component. C133807 PQ/CMC Test Category Terminology C60819 Assay A qualitative or quantitative analysis performed to determine the amount of a particular constituent in a sample or the biological or pharmacological properties of a drug. Assay Tests which measure the content of the active ingredient in the drug substance or drug product. Synonymous with strength or purity which is commonly used of define the content of the active ingredient in a drug product. [Source: Adapted from ICH Q6A and Q6B] Note: chiral purity, preservative content, Anti-Oxidant Concentration, Chelate Concentration, isomeric ratio. C133807 PQ/CMC Test Category Terminology C158425 Biological Properties Any effect a given chemical has on a living organism. Biological Properties Any effect a given material has on a living organism (e.g., microbial limits, endotoxin). C133807 PQ/CMC Test Category Terminology C158423 Chemical Impurity Any unwanted organic, inorganic, and residual solvents in drug substances and final products. Impurities Analytical procedures that determine the presence of a component of the material that is not the chemical entity defined as the material. C133807 PQ/CMC Test Category Terminology C17771 Chemical Properties General term for compositional, structural, and reactivity- affecting qualities of chemical compounds. Chemical Properties A characteristic of a material that is observed during a reaction in which the chemical composition or identity of the material is changed (e.g., combustibility, solubility, acidity/basicity). C133807 PQ/CMC Test Category Terminology C138993 Material Identification Tests that establishes the characteristic and uniqueness of the substance of interest and should be able to discriminate between compounds of closely related structures which are likely to be present. Identification Tests that establishes the characteristic and uniqueness of the substance of interest and should be able to discriminate between compounds of closely related structures which are likely to be present. [Source: ICH Q6A] C133807 PQ/CMC Test Category Terminology C158424 Physical Properties Any of the characteristics of a chemical that are not associated with a change in its composition and basic nature, including but not limited to its appearance, texture, color, smell, freezing point, boiling point, melting point, opacity, viscosity and density. Physical Properties Assessments of the characteristics of a material that are not associated with a change in its composition and basic nature, including but not limited to its texture, smell, freezing point, boiling point, melting point, opacity, viscosity and density. C133807 PQ/CMC Test Category Terminology C138990 Product Description/Appearance Tests using visual inspection to assess the physical state and color of the drug substance or product. Description An assessment of the physical state (e.g., color, shape, size) of the drug substance or product. [Source: Adapted from ICH Q6A] C133867 PQ/CMC Test Method Origin Terminology C96164 Code of Federal Regulations Method A method described in the Code of Federal Regulations. CFR A method described in the Code of Federal Regulations. C133867 PQ/CMC Test Method Origin Terminology C96102 Compendial Method Standardized methods and specification testing for generic pharmaceutical raw materials and finished products. Compendial Standardized methods and specification testing for generic pharmaceutical raw materials and finished products. C133867 PQ/CMC Test Method Origin Terminology C96103 Proprietary Method An analysis that contains protected intellectual property preventing full disclosure of information about the method and/or restricting or limiting the use or distribution of the method or materials for its performance without express permission or licensing. Proprietary An analysis that contains protected intellectual property preventing full disclosure of information about the method and/or restricting or limiting the use or distribution of the method or materials for its performance without express permission or licensing. C133868 PQ/CMC Test Usage Terminology C134029 Release Determination For determination of acceptability for use of a material, drug or a drug substance. Release For determination of acceptability for use of a material, drug or a drug substance. C133868 PQ/CMC Test Usage Terminology C134030 Stability Determination For determination of maintained performance parameters on storage over time, of a material, drug or a drug substance. Stability For determination of maintained performance parameters on storage over time, of a material, drug or a drug substance. C54456 SPL Pharmaceutical Dosage Form Terminology C42887 Aerosol Dosage Form Contents packaged under pressure that are released upon activation of an appropriate valve system. AEROSOL C54456 SPL Pharmaceutical Dosage Form Terminology C42888 Aerosol Foam Dosage Form A foam that is packaged under pressure and released upon activation of an appropriate valve system. AEROSOL, FOAM C54456 SPL Pharmaceutical Dosage Form Terminology C42889 Aerosol Spray Dosage Form A spray that is packaged under pressure and released upon activation of an appropriate valve system. AEROSOL, SPRAY C54456 SPL Pharmaceutical Dosage Form Terminology C60897 Augmented Cream Dosage Form A cream that is modified to enhance the release of active and/or inert ingredient(s). CREAM, AUGMENTED C54456 SPL Pharmaceutical Dosage Form Terminology C60957 Augmented Lotion Dosage Form A lotion that is modified to enhance the release of active and/or inert ingredient(s). LOTION, AUGMENTED C54456 SPL Pharmaceutical Dosage Form Terminology C60984 Augmented Ointment Dosage Form An ointment that is modified to enhance the release of active and/or inert ingredient(s). OINTMENT, AUGMENTED C54456 SPL Pharmaceutical Dosage Form Terminology C42890 Bead Dosage Form A solid in the shape of a small sphere. BEAD C54456 SPL Pharmaceutical Dosage Form Terminology C25158 Capsule Dosage Form A solid contained within either a hard or soft soluble shell, usually prepared from gelatin. CAPSULE C54456 SPL Pharmaceutical Dosage Form Terminology C100103 Cellular Sheet Dosage Form A skin graft sheet composed of viable cells layered on a supporting substrate. CELLULAR SHEET C54456 SPL Pharmaceutical Dosage Form Terminology C42892 Chewable Bar Dosage Form A bar designed to be chewed to release active and/or inert ingredient(s). BAR, CHEWABLE C54456 SPL Pharmaceutical Dosage Form Terminology C134876 Chewable Gel Dosage Form A formed or molded oral gel dosage form that maintains its shape, is elastic, and yields to mastication. Chewable Gel C54456 SPL Pharmaceutical Dosage Form Terminology C42893 Chewable Tablet Dosage Form A tablet that must be chewed to release the active and/or inert ingredient(s). TABLET, CHEWABLE C54456 SPL Pharmaceutical Dosage Form Terminology C42894 Chewing Gum Dosage Form A semi-solid composed of synthetic, polymerized polysaccharide and flavorings, intended to be chewed to release active and/or inert ingredient(s). GUM, CHEWING C54456 SPL Pharmaceutical Dosage Form Terminology C60884 Cloth Dosage Form A solid composed active and/or inert ingredient(s) in a woven absorbent material. CLOTH C54456 SPL Pharmaceutical Dosage Form Terminology C42895 Coated Capsule Dosage Form A capsule that contains an additional outer layer over the capsule shell. CAPSULE, COATED C54456 SPL Pharmaceutical Dosage Form Terminology C42896 Coated Pellet in Capsule Dosage Form A capsule composed of small globular masses covered with an outer shell. CAPSULE, COATED PELLETS C54456 SPL Pharmaceutical Dosage Form Terminology C42897 Coated Tablet Dosage Form A tablet whose outer shell is covered with a substance. TABLET, COATED C54456 SPL Pharmaceutical Dosage Form Terminology C60891 Concentrated Dosage Form A solution or suspension composed of active and/or inert ingredient(s) with increased strength in a reduced volume, which is usually diluted prior to administration. CONCENTRATE C54456 SPL Pharmaceutical Dosage Form Terminology C42899 Concentrated Injectable Solution Dosage Form A concentrate which is usually diluted prior to administration by injection. INJECTION, SOLUTION, CONCENTRATE C54456 SPL Pharmaceutical Dosage Form Terminology C42898 Concentrated Solution Dosage Form A concentrate which is usually diluted prior to administration and exists as a solution in its final form. SOLUTION, CONCENTRATE C54456 SPL Pharmaceutical Dosage Form Terminology C28944 Cream Dosage Form A semi-solid composed of an emulsion of lipids, hydrocarbons, waxes, or polyols in water. CREAM C54456 SPL Pharmaceutical Dosage Form Terminology C42901 Crystal Dosage Form A solid that consists of naturally produced angular solids composed of singular, repeating units that are systematically arranged in an evenly spaced lattice. CRYSTAL C54456 SPL Pharmaceutical Dosage Form Terminology C42902 Delayed Release Capsule Dosage Form A capsule covered with a substance that is designed to impede the immediate release of the active and/or inert ingredient(s) after administration. CAPSULE, DELAYED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42903 Delayed Release Granule Dosage Form A solid composed of small particles or grains and have been coated with a substance that is designed to impede the immediate release of the active and/or inert ingredient(s) after administration. GRANULE, DELAYED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C87540 Delayed Release Granule for Suspension Dosage Form A pharmaceutical dosage form comprised of delayed release granules designed to form a suspension. GRANULE FOR SUSPENSION, DELAYED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42997 Delayed Release Particle Tablet Dosage Form A tablet composed of individual fragments have been coated with a substance that is designed to impede the immediate release of the active and/or inert ingredient(s) after administration. TABLET, DELAYED RELEASE PARTICLES C54456 SPL Pharmaceutical Dosage Form Terminology C42904 Delayed Release Pellet in Capsule Dosage Form A capsule composed of active and/or inert ingredient(s) small, spherical structures that have been coated with a substance that is designed to impede the immediate release of the active and/or inert ingredient(s) after administration. CAPSULE, DELAYED RELEASE PELLETS C54456 SPL Pharmaceutical Dosage Form Terminology C42905 Delayed Release Tablet Dosage Form A tablet that has been coated with a substance that is designed to impede the immediate release of the active and/or inert ingredient(s) after administration. TABLET, DELAYED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42906 Dentifrice Gel Dosage Form A gel intended for use in the oral cavity to clean the teeth and maintain oral hygiene. GEL, DENTIFRICE C54456 SPL Pharmaceutical Dosage Form Terminology C42907 Dentifrice Paste Dosage Form A paste of mild abrasives, detergents, flavoring agents, binders, fluoride, and other active and/or inert ingredient(s). PASTE, DENTIFRICE C54456 SPL Pharmaceutical Dosage Form Terminology C42908 Dentifrice Powder Dosage Form A powder composed of a mild abrasives, detergents, flavoring agents, binders, fluoride, and other active and/or inert ingredient(s). POWDER, DENTIFRICE C54456 SPL Pharmaceutical Dosage Form Terminology C43525 Disc Dosage Form A flat, circular shaped form composed of a solid or powder that contains active and/or inert ingredient(s). DISC C54456 SPL Pharmaceutical Dosage Form Terminology C48624 Dosage Form Not Applicable An indication that the dosage form is not relevant or appropriate. NOT APPLICABLE C54456 SPL Pharmaceutical Dosage Form Terminology C60927 Dosage Form for Solution A substance intended for administration as a solution. FOR SOLUTION C54456 SPL Pharmaceutical Dosage Form Terminology C60928 Dosage Form for Suspension A substance intended for administration as a suspension. FOR SUSPENSION C54456 SPL Pharmaceutical Dosage Form Terminology C42679 Douche Dosage Form A substance intended for use as a vaginal irrigant. DOUCHE C54456 SPL Pharmaceutical Dosage Form Terminology C42763 Dressing Dosage Form A substance intended for administration in or on a wound. DRESSING C54456 SPL Pharmaceutical Dosage Form Terminology C60992 Drop Solution Dosage Form A solution intended for administration in a drop-wise fashion. SOLUTION/DROPS C54456 SPL Pharmaceutical Dosage Form Terminology C60995 Drop Suspension Dosage Form A suspension intended for administration in a drop-wise fashion. SUSPENSION/DROPS C54456 SPL Pharmaceutical Dosage Form Terminology C17423 Drug Delivery System Modern technology, distributed with or as a part of a drug product that allows for the uniform release or targeting of drugs to the body. DRUG DELIVERY SYSTEM SYSTEM C54456 SPL Pharmaceutical Dosage Form Terminology C42909 Effervescent Granule Dosage Form A granule composed of active and/or inert ingredient(s), and a mixture of acids and sodium bicarbonate, which release carbon dioxide when dissolved in water. GRANULE, EFFERVESCENT C54456 SPL Pharmaceutical Dosage Form Terminology C64884 Effervescent Powder Dosage Form A powder composed of active and/or inert ingredient(s), and a mixture of acids and sodium bicarbonate, which release carbon dioxide when dissolved in water. POWDER, EFFERVESCENT C54456 SPL Pharmaceutical Dosage Form Terminology C42910 Effervescent Tablet Dosage Form A tablet composed of active and/or inert ingredient(s), and a mixture of acids and sodium bicarbonate, which release carbon dioxide when dissolved in water. TABLET, EFFERVESCENT C54456 SPL Pharmaceutical Dosage Form Terminology C42911 Electrically Controlled Extended Release Patch Dosage Form A patch that composed of active and/or inert ingredient(s) whose release is controlled by electronic impulses that release ingredients at a controlled, prolonged rate so as to reduce dosing frequency. PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLED C54456 SPL Pharmaceutical Dosage Form Terminology C42912 Elixir Dosage Form A solution composed of a clear, sweetened hydroalcoholic liquid in which active and/or inert ingredient(s) are dissolved. ELIXIR C54456 SPL Pharmaceutical Dosage Form Terminology C42913 Emulsion Dosage Form A semi-solid composed of at least two immiscible liquids, one of which is dispersed as droplets within the other liquid, and stabilized with one or more emulsifying agents. EMULSION C54456 SPL Pharmaceutical Dosage Form Terminology C42914 Emulsion for Injection Dosage Form An emulsion intended for injection. INJECTION, EMULSION C54456 SPL Pharmaceutical Dosage Form Terminology C42915 Enema Dosage Form A solution or suspension intended for administration into the rectum. ENEMA C54456 SPL Pharmaceutical Dosage Form Terminology C42916 Extended Release Capsule Dosage Form A capsule designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. CAPSULE, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C124794 Extended Release Chewable Tablet A tablet that must be chewed in order to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. TABLET, CHEWABLE, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42917 Extended Release Coated Capsule Dosage Form A capsule covered with a thin layer of substance and is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. CAPSULE, COATED, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42918 Extended Release Coated Pellet Dosage Form A pellet covered with a thin layer of substance that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. PELLETS, COATED, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C60929 Extended Release Dosage Form for Suspension A substance that forms a suspension upon reconstitution and designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. FOR SUSPENSION, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C60926 Extended Release Fiber Dosage Form A solid in the shape of a slender, elongated thread that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. FIBER, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42928 Extended Release Film Coated Capsule Dosage Form A capsule covered with a thin layer of water soluble or insoluble polymer and is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. CAPSULE, FILM COATED, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42920 Extended Release Film Dosage Form A film that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. FILM, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42935 Extended Release Gel Forming Solution Dosage Form A solution that becomes gelatinous upon administration and is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. SOLUTION, GEL FORMING, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C69067 Extended Release Granule Dosage Form A solid in the shape of a small particle or grain designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. GRANULE, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42921 Extended Release Granule for Suspension Dosage Form A granule intended for administration as a suspension and designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. GRANULE, FOR SUSPENSION, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42922 Extended Release Insert Dosage Form An insert designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. INSERT, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C87538 Extended Release Intraruminal Device Dosage Form A pharmaceutical dosage form comprised of extended release agents for intraruminal administration. INTRARUMINAL DEVICE, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C60934 Extended Release Liquid Dosage Form A solution or suspension that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. LIQUID, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42923 Extended Release Patch Dosage Form A patch designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. PATCH, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42924 Extended Release Suppository Dosage Form A suppository that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. SUPPOSITORY, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42925 Extended Release Suspension Dosage Form A suspension that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. SUSPENSION, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42927 Extended Release Tablet Dosage Form A tablet designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. TABLET, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42929 Extract Dosage Form A distillate composed of active and/or inert ingredient(s) extracted from plant or animal matter, and represented in concentrated form. EXTRACT C54456 SPL Pharmaceutical Dosage Form Terminology C42930 Film Coated Extended Release Tablet Dosage Form A tablet covered with a thin layer of water soluble or insoluble polymer and is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. TABLET, FILM COATED, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42931 Film Coated Tablet Dosage Form A tablet covered with a thin layer of water soluble or insoluble polymer. TABLET, FILM COATED C54456 SPL Pharmaceutical Dosage Form Terminology C42932 Film Dosage Form A thin layer of water soluble or insoluble polymer intended to coat the site of administration. FILM C54456 SPL Pharmaceutical Dosage Form Terminology C42933 Gas Dosage Form An elastic aeriform fluid in which the molecules are separated from one another and have freedom of movement. GAS C54456 SPL Pharmaceutical Dosage Form Terminology C42934 Gel Dosage Form A semi-solid composed of a solid, three dimensional, cross linked matrix of polymers within a liquid, yielding a jelly-like material unable to flow at steady state. GEL C54456 SPL Pharmaceutical Dosage Form Terminology C60994 Gel Forming Drop Solution Dosage Form A solution intended for administration in a drop-wise fashion; it becomes gelatinous upon administration. SOLUTION, GEL FORMING/DROPS C54456 SPL Pharmaceutical Dosage Form Terminology C42936 Gelatin Coated Capsule Dosage Form A capsule covered with a thin layer of gelatin. CAPSULE, GELATIN COATED C54456 SPL Pharmaceutical Dosage Form Terminology C42937 Globule Dosage Form A solid composed of sucrose, lactose or other polysaccharides formed into small globular pellets impregnated with active and/or inert ingredient(s). GLOBULE C54456 SPL Pharmaceutical Dosage Form Terminology C42938 Granule Dosage Form A solid composed of small particles or grains. GRANULE C54456 SPL Pharmaceutical Dosage Form Terminology C42939 Granule for Solution Dosage Form A granule intended for administration as a solution. GRANULE, FOR SOLUTION C54456 SPL Pharmaceutical Dosage Form Terminology C42940 Granule for Suspension Dosage Form A granule intended for administration as a suspension. GRANULE, FOR SUSPENSION C54456 SPL Pharmaceutical Dosage Form Terminology C42942 Implant Dosage Form A solid intended for insertion securely within the body. IMPLANT C54456 SPL Pharmaceutical Dosage Form Terminology C42943 Implantable Pellet Dosage Form A pellet intended for insertion securely within the body. PELLET, IMPLANTABLE C54456 SPL Pharmaceutical Dosage Form Terminology C42944 Inhalant Dosage Form Vaporized active and/or inert ingredient(s) intended for administration by inhalation. INHALANT C54456 SPL Pharmaceutical Dosage Form Terminology C42946 Injectable Dosage Form A substance intended for injection. INJECTION C54456 SPL Pharmaceutical Dosage Form Terminology C42926 Injectable Extended Release Suspension Dosage Form A suspension intended for injection that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. INJECTION, SUSPENSION, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C113106 Injectable Foam Dosage Form A foam intended for parenteral administration. INJECTABLE FOAM C54456 SPL Pharmaceutical Dosage Form Terminology C42950 Injectable Lipid Complex Dosage Form A substance composed of complexed active and/or inert ingredient(s) with natural or synthetic lipids that is intended for injection. INJECTION, LIPID COMPLEX C54456 SPL Pharmaceutical Dosage Form Terminology C42951 Injectable Liposomal Suspension Dosage Form A suspension composed of active and/or inert ingredient(s) encapsulated in liposomes and intended for injection. INJECTION, SUSPENSION, LIPOSOMAL C54456 SPL Pharmaceutical Dosage Form Terminology C42945 Injectable Solution Dosage Form A solution intended for injection. INJECTION, SOLUTION C54456 SPL Pharmaceutical Dosage Form Terminology C42988 Injectable Sonicated Suspension Dosage Form A suspension intended for injection and is sonicated while a gas is bubbled through the suspension resulting in the creation of microspheres by the solid particles. INJECTION, SUSPENSION, SONICATED C54456 SPL Pharmaceutical Dosage Form Terminology C42995 Injectable Suspension Dosage Form A suspension intended for injection. INJECTION, SUSPENSION C54456 SPL Pharmaceutical Dosage Form Terminology C60933 Insert Dosage Form A solid or semi-solid intended for administration within the body. INSERT C54456 SPL Pharmaceutical Dosage Form Terminology C64984 Intracameral Route of Administration Administration of a medicinal product directly into the anterior chamber of the eye. INTRACAMERAL C54456 SPL Pharmaceutical Dosage Form Terminology C47915 Intrauterine Device Dosage Form A solid intended for placement within the uterine cavity where active and/or inert ingredient(s) are released from an apparatus at a controlled rate. INTRAUTERINE DEVICE C54456 SPL Pharmaceutical Dosage Form Terminology C42947 Irrigant Dosage Form A solution or suspension used to bathe or flush open wounds or body cavities. IRRIGANT C54456 SPL Pharmaceutical Dosage Form Terminology C42948 Jelly Dosage Form A semi-solid composed of suspensions of active and/or inert ingredient(s) in any type of highly viscous material, including gelatin or gel. The structural matrix of the jelly contains high levels of liquid. JELLY C54456 SPL Pharmaceutical Dosage Form Terminology C47916 Kit Dosage Form A collection of unrelated materials that are used together to orchestrate dosage administration. KIT C54456 SPL Pharmaceutical Dosage Form Terminology C42949 Liniment Dosage Form A semi-solid with viscosity similar to that of a lotion, which is intended for topical use and must be rubbed into the site of administration to release the active and/or inert ingredient(s). LINIMENT C54456 SPL Pharmaceutical Dosage Form Terminology C60931 Liposomal Injection Dosage Form A substance composed of active and/or inert ingredient(s) encapsulated in liposomes and intended for injection. INJECTABLE, LIPOSOMAL C54456 SPL Pharmaceutical Dosage Form Terminology C42952 Lipstick Dosage Form A solid or semi-solid with a waxy consistency in the shape of a stick and intended for use on the lips. LIPSTICK C54456 SPL Pharmaceutical Dosage Form Terminology C42953 Liquid Dosage Form A substance in the fluid state of matter having no fixed shape but a fixed volume. LIQUID C54456 SPL Pharmaceutical Dosage Form Terminology C42954 Liquid Filled Capsule Dosage Form A capsule composed of liquid covered with an outer shell, which is usually prepared from gelatin. CAPSULE, LIQUID FILLED C54456 SPL Pharmaceutical Dosage Form Terminology C29167 Lotion Dosage Form A semi-solid composed of an oil in water emulsion, with lower viscosity than cream or gel. LOTION C54456 SPL Pharmaceutical Dosage Form Terminology C60958 Lotion Shampoo Dosage Form A lotion composed of anionic surfactant intended for administration to the hair or scalp. LOTION/SHAMPOO C54456 SPL Pharmaceutical Dosage Form Terminology C42955 Lozenge Dosage Form A solid composed of active and/or inert ingredient(s), sweeteners, other flavorings and mucilage, intended for oral administration. LOZENGE C54456 SPL Pharmaceutical Dosage Form Terminology C87541 Lyophilized Powder Dosage Form A pharmaceutical dosage form comprised of lyophilized powder. POWDER, LYOPHILIZED C54456 SPL Pharmaceutical Dosage Form Terminology C42956 Lyophilized Powder for Extended Release Injectable Suspension Dosage Form A freeze dried powder intended for injection following reconstitution with a suitable solvent to form a suspension that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42959 Lyophilized Powder for Injectable Liposomal Suspension Dosage Form A freeze dried powder composed of active and/or inert ingredient(s) encapsulated in liposomes and intended for injection following reconstitution with a suitable solvent to form a suspension. INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION C54456 SPL Pharmaceutical Dosage Form Terminology C42957 Lyophilized Powder for Injectable Solution Dosage Form A freeze dried powder intended for injection following reconstitution with a suitable solvent to form a solution. INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION C54456 SPL Pharmaceutical Dosage Form Terminology C42958 Lyophilized Powder for Injectable Suspension Dosage Form A freeze dried powder intended for injection following reconstitution with a suitable solvent to form a suspension. INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION C54456 SPL Pharmaceutical Dosage Form Terminology C42960 Metered Aerosol Dosage Form An aerosol contained in a device with valves that permits the release of a specified quantity of active and/or inert ingredient(s) upon activation. AEROSOL, METERED C54456 SPL Pharmaceutical Dosage Form Terminology C60930 Metered Gel Dosage Form A gel contained in a device with valves that permits the release of a uniform dose of gel that composed of active and/or inert ingredient(s) upon activation. GEL, METERED C54456 SPL Pharmaceutical Dosage Form Terminology C42961 Metered Powder Dosage Form A powder contained in a device with valves that permits the dispensing of active and/or inert ingredient(s) upon activation. POWDER, METERED C54456 SPL Pharmaceutical Dosage Form Terminology C42962 Metered Spray Dosage Form A spray contained in a device with valves that permits the dispensing of a specified quantity of active and/or inert ingredient(s) upon activation. SPRAY, METERED C54456 SPL Pharmaceutical Dosage Form Terminology C29269 Mouthwash Dosage Form A solution or suspension intended for oral administration, for its deodorizing or antiseptic effects in the oral cavity. Usually, the mouthwash is swished around the mouth and expelled. MOUTHWASH C54456 SPL Pharmaceutical Dosage Form Terminology C42963 Multilayered Extended Release Tablet Dosage Form A tablet composed of active and/or inert ingredient(s) that have been compressed into multiple layers and is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. TABLET, MULTILAYER, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42964 Multilayered Tablet Dosage Form A tablet composed of active and/or inert ingredient(s) that have been compressed to form a tablet that contains multiple layers. TABLET, MULTILAYER C54456 SPL Pharmaceutical Dosage Form Terminology C42965 Oil Dosage Form A solution or suspension that is hydrophobic, soluble in organic solvents, and liquid at ambient temperature. OIL C54456 SPL Pharmaceutical Dosage Form Terminology C42966 Ointment Dosage Form A semi-solid, viscous in texture, that may be composed of a variety of bases including hydrocarbons, emulsifiers or vegetable oils, and mixed with active and/or inert ingredient(s). OINTMENT C54456 SPL Pharmaceutical Dosage Form Terminology C61006 Orally Disintegrating Delayed Release Tablet Dosage Form A tablet that disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue but is also designed to impede the immediate release of the active and/or inert ingredient(s) after administration. TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42999 Orally Disintegrating Tablet Dosage Form A tablet which disintegrates and dissolves quickly (usually within a matter of seconds) in the mouth. Additional water to complete dissolution is not necessary. TABLET, ORALLY DISINTEGRATING C54456 SPL Pharmaceutical Dosage Form Terminology C42967 Paste Dosage Form A semi-solid composed of a large proportion of solids and finely dispersed active and/or inert ingredient(s) in a fat-based vehicle. PASTE C54456 SPL Pharmaceutical Dosage Form Terminology C60985 Pastille Dosage Form A solid or semi-solid composed of a lozenge, that contains active and/or inert ingredient(s) that dissolves when sucked in the mouth. PASTILLE C54456 SPL Pharmaceutical Dosage Form Terminology C42968 Patch Dosage Form A solid composed of an impermeable occlusive backing and a formulation matrix in which the active and/or inert ingredient(s) are dissolved or dispersed; possibly includes an adhesive layer. PATCH C54456 SPL Pharmaceutical Dosage Form Terminology C42969 Pellet Dosage Form A solid composed of a small granular or compressed mass that contains highly purified active and/or inert ingredient(s). PELLET C54456 SPL Pharmaceutical Dosage Form Terminology C87542 Pendant Dosage Form A pharmaceutical dosage form containing active substance(s) delivered via pendant. PENDANT C54456 SPL Pharmaceutical Dosage Form Terminology C25394 Pill Dosage Form A solid composed of a small, round object composed of active and/or inert ingredient(s). PILL C54456 SPL Pharmaceutical Dosage Form Terminology C42970 Plaster Dosage Form A semi-solid composed of a soft, smooth mass with relatively thick consistency and strong adhesiveness that becomes solid when dry. PLASTER C54456 SPL Pharmaceutical Dosage Form Terminology C47913 Poultice Dosage Form A semi-solid composed of a soft, moist mass that is made by wetting an absorbent solid substance. POULTICE C54456 SPL Pharmaceutical Dosage Form Terminology C42971 Powder Aerosol Dosage Form A powder composed of active and/or inert ingredient(s) and packaged under pressure. Ingredients are released upon activation of an appropriate valve system. AEROSOL, POWDER C54456 SPL Pharmaceutical Dosage Form Terminology C42972 Powder Dosage Form A solid composed of a mixture of dry, finely divided active and/or inert ingredient(s). POWDER C54456 SPL Pharmaceutical Dosage Form Terminology C42977 Powder for Injectable Extended Release Suspension Dosage Form A powder intended for injection following reconstitution to form a suspension that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE C54456 SPL Pharmaceutical Dosage Form Terminology C42974 Powder for Injectable Solution Dosage Form A powder intended for injection following reconstitution to form a solution. INJECTION, POWDER, FOR SOLUTION C54456 SPL Pharmaceutical Dosage Form Terminology C42976 Powder for Injectable Suspension Dosage Form A powder intended for injection following reconstitution to form a suspension. INJECTION, POWDER, FOR SUSPENSION C54456 SPL Pharmaceutical Dosage Form Terminology C42973 Powder for Solution Dosage Form A powder that yields a solution following reconstitution with an appropriate liquid. POWDER, FOR SOLUTION C54456 SPL Pharmaceutical Dosage Form Terminology C42975 Powder for Suspension Dosage Form A powder that forms a suspension when reconstituted with a liquid solution. POWDER, FOR SUSPENSION C54456 SPL Pharmaceutical Dosage Form Terminology C60988 Ring Dosage Form A solid composed active and/or inert ingredient(s) of in the shape of a hoop. RING C54456 SPL Pharmaceutical Dosage Form Terminology C42979 Rinse Dosage Form A solution or suspension intended for irrigation purposes. RINSE C54456 SPL Pharmaceutical Dosage Form Terminology C42980 Salve Dosage Form A semi-solid composed of a thick, fat or wax-based ointment or cerate with a consistency somewhere between an ointment and a plaster. SALVE C54456 SPL Pharmaceutical Dosage Form Terminology C42981 Shampoo Dosage Form A solution or suspension composed of an anionic surfactant and intended for administration to the hair and/or scalp. SHAMPOO C54456 SPL Pharmaceutical Dosage Form Terminology C42982 Shampoo Suspension Dosage Form A suspension composed of anionic surfactant and intended for administration to the hair and/or scalp. SHAMPOO, SUSPENSION C54456 SPL Pharmaceutical Dosage Form Terminology C87537 Smoke Paper Dosage Form A pharmaceutical dosage form in paper; when lit, it delivers medicated smoke. SMOKE PAPER C54456 SPL Pharmaceutical Dosage Form Terminology C87536 Smoke Stick Dosage Form A pharmaceutical dosage form in the shape of a stick; when lit, it delivers medicated smoke. SMOKE STICK C54456 SPL Pharmaceutical Dosage Form Terminology C42983 Soap Dosage Form An anionic surfactant for cleansing. SOAP C54456 SPL Pharmaceutical Dosage Form Terminology C42984 Soluble Film Dosage Form A film that will dissolve in a liquid solvent to form a solution. FILM, SOLUBLE C54456 SPL Pharmaceutical Dosage Form Terminology C42985 Soluble Tablet Dosage Form A tablet that will dissolve in a liquid solvent to form a solution. TABLET, SOLUBLE C54456 SPL Pharmaceutical Dosage Form Terminology C42986 Solution Dosage Form A clear, homogeneous liquid composed of one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents. SOLUTION C54456 SPL Pharmaceutical Dosage Form Terminology C42987 Solution for Slush Dosage Form A solution composed of an iced saline slurry with or without active and/or inert ingredient(s) intended to induce regional hypothermia from the point of administration. SOLUTION, FOR SLUSH C54456 SPL Pharmaceutical Dosage Form Terminology C47912 Sponge Dosage Form A solid composed of a porous, interlacing, absorbent, usually shape retaining material, such as cellulose wood fibers or plastic polymer form. SPONGE C54456 SPL Pharmaceutical Dosage Form Terminology C42989 Spray Dosage Form A solution or suspension composed of active and/or inert ingredient(s) in oil or water, typically dispensed from an atomizer or nebulizer. SPRAY C54456 SPL Pharmaceutical Dosage Form Terminology C42990 Spray Suspension Dosage Form A spray composed of a suspension that contains active and/or inert ingredient(s). SPRAY, SUSPENSION C54456 SPL Pharmaceutical Dosage Form Terminology C42991 Stick Dosage Form A solid composed active and/or inert ingredient(s) in a long, slender cylindrical shape. STICK C54456 SPL Pharmaceutical Dosage Form Terminology C47914 Strip Dosage Form A solid composed of active and/or inert ingredient(s) in a long narrow piece of material. STRIP C54456 SPL Pharmaceutical Dosage Form Terminology C42992 Sugar Coated Tablet Dosage Form A tablet covered with sugar. TABLET, SUGAR COATED C54456 SPL Pharmaceutical Dosage Form Terminology C42993 Suppository Dosage Form A solid or semi-solid composed of active and/or inert ingredient(s) in a wax, fat or a glycerin gelatin jelly and that is conical or oval in shape. It is intended to be inserted into a body orifice. SUPPOSITORY C54456 SPL Pharmaceutical Dosage Form Terminology C42994 Suspension Dosage Form Insoluble solid particles composed of active and/or inert ingredient(s) that are dispersed in a liquid. SUSPENSION C54456 SPL Pharmaceutical Dosage Form Terminology C47898 Swab Dosage Form A solid composed of a small piece of absorbent material attached to one end of a small stick. SWAB C54456 SPL Pharmaceutical Dosage Form Terminology C42996 Syrup Dosage Form A solution or suspension composed of a viscid vehicle that contains a high concentration of sucrose or other sugars and active and/or inert ingredient(s). SYRUP C54456 SPL Pharmaceutical Dosage Form Terminology C60997 Tablet Coated Particle Dosage Form A tablet composed of a conglomerate of particles that contains active and/or inert ingredient(s) that have been individually covered with a coating. TABLET, COATED PARTICLES C54456 SPL Pharmaceutical Dosage Form Terminology C42998 Tablet Dosage Form A solid composed of a mixture of that active and/or inert ingredient(s) are pressed or compacted together, usually in the form of a relatively flat and round, square or oval shape. TABLET C54456 SPL Pharmaceutical Dosage Form Terminology C61004 Tablet for Solution Dosage Form A tablet that changes into a solution when added to a liquid solvent. TABLET, FOR SOLUTION C54456 SPL Pharmaceutical Dosage Form Terminology C61005 Tablet for Suspension Dosage Form A tablet that changes into a suspension when added to a liquid solution. TABLET, FOR SUSPENSION C54456 SPL Pharmaceutical Dosage Form Terminology C147579 Tablet with Sensor Dosage Form A solid dosage form containing medicinal substances, with or without suitable diluents, plus an ingestible sensor that communicates with medical devices that are usually located outside of the body. Tablet with Sensor C54456 SPL Pharmaceutical Dosage Form Terminology C87539 Tag Dosage Form A pharmaceutical dosage form containing active substance(s) that are delivered via a tag device. TAG C54456 SPL Pharmaceutical Dosage Form Terminology C47892 Tampon Dosage Form A solid composed of a plug made from absorbent material. TAMPON C54456 SPL Pharmaceutical Dosage Form Terminology C47897 Tape Dosage Form A solid composed of narrow woven fabric or a narrow extruded synthetic material, usually with an adhesive on one or both sides. TAPE C54456 SPL Pharmaceutical Dosage Form Terminology C43000 Tincture Dosage Form A solution composed of an alcoholic extract or solution of nonvolatile active and/or inert ingredient(s). TINCTURE C54456 SPL Pharmaceutical Dosage Form Terminology C43001 Troche Dosage Form A solid discoid composed of active and/or inert ingredient(s) in a suitably flavored base, that dissolves when sucked in the mouth. TROCHE C54456 SPL Pharmaceutical Dosage Form Terminology C43003 Wafer Dosage Form A solid composed of a thin slice of material that contain active and/or inert ingredient(s). WAFER C168632 SPL UCUM Terminology C70534 50 Percent Cell Culture Infective Dose A potency unit defined as a minimal dose of infectious material at which preparation causes cytopathic effects (changes in the morphology and metabolism of cell culture cells, indicating cell death, due to suspected infection) in the 50% of the cell culture-containing vessels inoculated with that dilution of infectious material. [CCID_50] CELL CULTURE INFECTIOUS DOSE 50% C168632 SPL UCUM Terminology C70503 Allergy Unit A biological potency unit assigned to several standardized allergenic extracts, following in-vitro comparison of the test extract to an FDA CBER reference standard. The FDA CBER reference standard may be assigned a specific AU unitage based on quantitative skin testing in allergic individuals, or based on specific allergen content. [AU] ALLERGY UNITS C168632 SPL UCUM Terminology C92953 Amb a 1 Unit An arbitrary unit for the measurement of Amb a 1 (or Antigen E), a 38 kD glycoprotein that is the major allergen in short ragweed pollen allergen extracts. [Amb'a'1'U] Amb a 1 units C168632 SPL UCUM Terminology C75765 Arbitrary Unit A single undivided thing (unit) based on or subject to individual judgment or preference, and not by necessity, reason, or principle. [arb'U] ARBITRARY UNITS C168632 SPL UCUM Terminology C70505 Bioequivalent Allergy Unit A unit used for standardization of an allergenic product based on evaluation of product potency against reference standard in combined in vivo (skin test) and in vitro (IgE-based ELISA) testing. [BAU] BIOEQUIVALENT ALLERGY UNITS C168632 SPL UCUM Terminology C92952 Centesimal Korsakovian Series of Attenuation Preparation of a homeopathic substance with a ratio of one part original material to 100 parts of water; a faster and cost-effective dilution method developed by Semyon Korsakov. {kp_C} HOMEOPATHIC POTENCY OF CENTESIMAL KORSAKOVIAN SERIES C168632 SPL UCUM Terminology C88109 Centesimal Series of Attenuation Preparation of a homeopathic substance with a ratio of one part original material to 100 parts of carrier or solvent, traditionally lactose, water or ethanol. [hp_C] HOMEOPATHIC POTENCY OF CENTESIMAL SERIES C168632 SPL UCUM Terminology C68742 Colony Forming Unit The minimum number of separable cells which is able to produce a detectable colony of progeny. Examples of CFU usage include, but are not limited to, the measurement of the number of viable bacteria present in the environment, and the ability of stem cells to produce cells of single or multiple lineages. [CFU] COLONY FORMING UNITS C168632 SPL UCUM Terminology C48466 Curie A unit of radioactivity in the CGS system, defined as 3.7 E10 atomic disintegrations or other nuclear transformations per second. One curie is equal to 37 gigabecquerels. Ci CURIE C168632 SPL UCUM Terminology C70501 D Antigen Unit A unit of potency of poliovirus vaccine used for poliomyelitis prevention. The unit is poliovirus type-specific. [D'ag'U] D-ANTIGEN UNITS C168632 SPL UCUM Terminology C25301 Day The time for Earth to make a complete rotation on its axis; ordinarily divided into twenty-four hours, equal to 86 400 seconds. This also refers to a specific day. d DAY C168632 SPL UCUM Terminology C64697 Deciliter The unit of volume equal to one tenth of a liter. Accepted for use with the SI. dL DECILITER C168632 SPL UCUM Terminology C88111 Decimal Series of Attenuation Preparation of a homeopathic substance with a ratio of one part original material to 10 parts of carrier or solvent, traditionally lactose, water or ethanol. [hp_X] HOMEOPATHIC POTENCY OF DECIMAL SERIES C168632 SPL UCUM Terminology C42559 Degree Celsius A unit of temperature of the temperature scale designed so that the freezing point of water is 0 degrees and the boiling point is 100 degrees at standard atmospheric pressure. The current official definition of the Celsius sets 0.01 C to be at the triple point of water and a degree to be 1/273.16 of the difference in temperature between the triple point of water and absolute zero. One degree Celsius represents the same temperature difference as one Kelvin. Cel degree Celsius C168632 SPL UCUM Terminology C44277 Degree Fahrenheit A unit of temperature of the temperature scale designed so that the freezing point of water is 32 degrees and the boiling point is 212 degrees, placing the boiling and melting points of water 180 degrees apart. One degree Fahrenheit is 5/9ths of a kelvin (or of a degree Celsius), and minus 40 degrees Fahrenheit is equal to minus 40 degrees Celsius. [degF] degree Fahrenheit C168632 SPL UCUM Terminology C68667 Degree Unit of Plane Angle A unit of plane angle measurement equal to the length of the arc cut out by the angle, divided by the circumference of the circle, and multiplied by 360. The symbol for degrees is a small superscript circle. One radian is about 57 degrees and one degree is pi/180 radians. deg degree Angle C168632 SPL UCUM Terminology C96599 Ehrlich Unit A unit of measure equal to one milligram of urobilinogen per deciliter. [EU] Ehrlich unit C168632 SPL UCUM Terminology C75303 Focus Forming Unit A quantitative unit of measure of cell clusters of a specific interest. [FFU] FOCUS-FORMING UNITS C168632 SPL UCUM Terminology C48155 Gram The metric unit of mass equal to one thousandth of a kilogram. One gram equals approximately 15.432 grains or 0.035 273 966 ounce. g GRAM C168632 SPL UCUM Terminology C25529 Hour A unit measure of time equal to 3,600 seconds or 60 minutes. It is approximately 1/24 of a median day. h HOUR C168632 SPL UCUM Terminology C48579 International Unit The unitage assigned by the WHO to International Biological Standards - substances, classed as biological according to the criteria provided by WHO Expert Committee on Biological Standardization (e.g. hormones, enzymes, and vaccines), to enable the results of biological and immunological assay procedures to be expressed in the same way throughout the world. The definition of an international unit is generally arbitrary and technical, and has to be officially approved by the International Conference for Unification of Formulae. [iU] INTERNATIONAL UNITS C168632 SPL UCUM Terminology C70511 Kilobecquerel A unit of radioactivity equal to 10E3 nuclear disintegrations or other nuclear transformations per second, or to 10E3 becquerels. kBq kilobecquerel C168632 SPL UCUM Terminology C28252 Kilogram A basic SI unit of mass. It is defined as the mass of an international prototype in the form of a platinum-iridium cylinder kept at Sevres in France. A kilogram is equal to 1,000 grams and 2.204 622 6 pounds. kg KILOGRAM C168632 SPL UCUM Terminology C73566 Limit Flocculation Unit [Lf] LIMIT OF FLOCCULATION C168632 SPL UCUM Terminology C48505 Liter The non-SI unit of volume accepted for use with the SI. One liter is equal to cubic decimeter, or one thousandth of cubic meter, or 1000 cubic centimeters, or approximately 61.023 744 cubic inches. L LITER C168632 SPL UCUM Terminology C48507 Microcurie A unit of radioactivity equal to one millionth of a curie or 37 kilobecquerels, and corresponding to a radioactivity of 37 000 atomic disintegrations per second. uCi MICROCURIE C168632 SPL UCUM Terminology C48152 Microgram A metric unit of mass equal to one millionth of a gram or one thousandth of a milligram. ug MICROGRAM C168632 SPL UCUM Terminology C48153 Microliter A unit of volume accepted for use with the SI and equal to one millionth of a liter (10E-6 liter). uL MICROLITER C168632 SPL UCUM Terminology C48509 Micromole A unit of amount of substance equal to a millionth of a mole. umol MICROMOLE C168632 SPL UCUM Terminology C48510 Micron A unit of length in metric system equal to 10E-6 meter, or micrometer. um MICRON C168632 SPL UCUM Terminology C88110 Millesimal Series of Attenuation Preparation of a homeopathic substance with a ratio of one part original material to 1000 parts of carrier or solvent, traditionally lactose, water or ethanol. [hp_M] HOMEOPATHIC POTENCY OF MILLESIMAL SERIES C168632 SPL UCUM Terminology C48511 Millicurie A unit of radioactivity equal to one thousandth of a curie or 37 megabecquerels, and corresponding to a radioactivity of 37 millions of atomic disintegrations per second. mCi MILLICURIE C168632 SPL UCUM Terminology C48512 Milliequivalent A unit of relative amount of a substance equal to one thousandth of an equivalent weight. meq MILLIEQUIVALENT C168632 SPL UCUM Terminology C28253 Milligram A metric unit of mass equal to one thousandth of a gram or 1000 micrograms. One milligram equals approximately 0.015 432 grain or 35.274 x 10E-6 ounce. mg MILLIGRAM C168632 SPL UCUM Terminology C28254 Milliliter A unit of volume equal to one millionth (10E-6) of a cubic meter, one thousandth of a liter, one cubic centimeter, or 0.061023 7 cubic inch. A cubic centimeter is the CGS unit of volume. mL MILLILITER C168632 SPL UCUM Terminology C28251 Millimeter A metric unit of length equal to one thousandth of a meter (10E-3 meter) or approximately 0.03937 inch. mm MILLIMETER C168632 SPL UCUM Terminology C48513 Millimole A unit of amount of substance equal to 0.001 mole. mmol MILLIMOLE C168632 SPL UCUM Terminology C67318 Milliosmole A unit of osmotic pressure equal to one thousandth of osmole or osmotic pressure of 0.001 molar solution of a substance that does not dissociate. mosm milliosmole C168632 SPL UCUM Terminology C48154 Minute A unit measure of time equal to 60 seconds. min MINUTE C168632 SPL UCUM Terminology C42539 Mole A unit of amount of substance, one of the seven base units of the International System of Units (Systeme International d'Unites, SI). It is the amount of substance that contains as many elementary units as there are atoms in 0.012 kg of carbon-12. When the mole is used, the elementary entities must be specified and may be atoms, molecules, ions, electrons, other particles, or specified groups of such particles. mol MOLE C168632 SPL UCUM Terminology C29846 Month One of the 12 divisions of a year as determined by a calendar. It corresponds to the unit of time of approximately to one cycle of the moon's phases, about 30 days or 4 weeks. mo MONTH C168632 SPL UCUM Terminology C48516 Nanogram The metric unit of mass equal to one billionth of a gram (10E-9 gram) or one thousandth of a milligram. ng NANOGRAM C168632 SPL UCUM Terminology C48517 Nanomole A unit of amount of substance equal to 10E-9 mole. nmol NANOMOLE C168632 SPL UCUM Terminology C66832 One The smallest natural number and quantity it denotes: a single entity, unit, or object. 1 1* C168632 SPL UCUM Terminology C48523 Part Per Million A unit of proportion equal to 10E-6. [ppm] parts per million  C168632 SPL UCUM Terminology C171022 Particle Total Count A quantitative value for the total particles in a sample. {tot} particles total count C168632 SPL UCUM Terminology C64551 Picogram The metric unit of mass equal to one trillionth of a gram (10E-12 gram). pg picogram C168632 SPL UCUM Terminology C67264 Plaque Forming Unit A measure of viable infectious entities (e.g. viral particles or group of particles) in the specimen or product defined as the smallest quantity that can produce a cytopathic effect in the host cell culture challenged with the defined inoculum, visible under the microscope and/or to the naked eye as a plaque. A number of plaque forming units (PFU) per unit volume is a conventional way to refer the titer of an infective entity in a specimen or preparation. [PFU] PLAQUE-FORMING UNITS C168632 SPL UCUM Terminology C48533 Protein Nitrogen Unit An unit used to quantitate protein nitrogen in acid precipitate samples based on micro-Kjeldahl measurement. One protein nitrogen unit represents 0.01 microgram of total protein nitrogen in the extracted samples. [PNU] PROTEIN NITROGEN UNITS C168632 SPL UCUM Terminology C88108 Quintamillesimal Series of Attenuation Preparation of a homeopathic substance with a ratio of one part original material to 50,000 parts of carrier or solvent, traditionally this is lactose, water or ethanol. [hp_Q] HOMEOPATHIC POTENCY OF QUINTAMILLESIMAL SERIES C168632 SPL UCUM Terminology C42535 Second A unit of time, one of the seven base units of the International System of Units (Systeme International d'Unites, SI). The second is the duration of 919 263 177 0 periods of the specified light radiation corresponding to the transition between the two hyperfine levels of the caesium 133 atom in its ground state at 0 K. According to the convention, 60 seconds constitute one minute; 3,600 seconds constitute one hour. s SECOND C168632 SPL UCUM Terminology C48460 Square Centimeter A CGS unit of area measurement equal to a square measuring one centimeter on each side. One square centimeter is equal to 10E-4 square meter. cm2 SQUARE CENTIMETER C168632 SPL UCUM Terminology C67450 Tissue Culture Infectious Dose 50% A potency unit defined as a minimal dose of infectious material at which preparation causes cytopathic effects (changes in the morphology and metabolism of tissue culture cells, indicating cell death, due to suspected infection) in the 50% of the tissue culture-containing flasks inoculated with that dilution of infectious material in the product potency assay or pathogen activity assay. [TCID_50] TISSUE CULTURE INFECTIOUS DOSE 50% C168632 SPL UCUM Terminology C44278 Unit A single undivided thing occurring in the composition of something else. U UNIT - CATALYTIC ACTIVITY C168632 SPL UCUM Terminology C48469 United States Pharmacopeia Unit An arbitrary unit for the measurement of the biologic activity of antibiotics, endocrine preparations, sera, toxins, vaccines, and related products established by the United States Pharmacopeia (USP), the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the US. For each substance to which this unit applies, USP determines a Reference Standard and a specified assay. If the standard is the same as the WHO-approved International Biological Reference Preparation, and the same assay procedure was used for the biological effect evaluation, the USP unit is considered equal to International Unit. [USP'U] UNITED STATES PHARMACOPEIA UNIT C168632 SPL UCUM Terminology C29844 Week Any period of seven consecutive days. wk WEEK C168632 SPL UCUM Terminology C29848 Year A period of time that it takes for Earth to make a complete revolution around the sun, approximately 365 days; a specific one year period. a YEAR C168632 SPL UCUM Terminology C45997 pH Quantity of dimension one used to express on a scale from 0 to 14 the amount-of-substance concentration of hydrogen ion of dilute aqueous solution, calculated as the logarithm of the reciprocal of hydrogen-ion concentration in gram atoms per liter. [pH] pH