D 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. D 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. D 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). D C133859 PQ/CMC Manufacturing Site Unique Identifier Type Terminology C17998 Unknown Not known, observed, recorded; or reported as unknown by the data contributor. Unknown Not known, not observed, not recorded, or refused. D C133869 PQ/CMC Testing 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. D C133869 PQ/CMC Testing 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. D C133869 PQ/CMC Testing 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). D C133869 PQ/CMC Testing Site Unique Identifier Type Terminology C17998 Unknown Not known, observed, recorded; or reported as unknown by the data contributor. Unknown Not known, not observed, not recorded, or refused. D C176677 PQ/CMC Units of Measure Terminology C64559 Atomic Mass Unit A small unit of mass used to express atomic and molecular masses. u atomic mass unit D C185183 PQ/CMC Retest Date Classification Terminology C185182 Master File or Application Approved Indicator An approved indicator for an application or a master file when the Expiration Date Classification or Retest Date Classification is set to "Approved". Approved After an application or a master file has been approved, then the Expiration Date Classification or Retest Date Classification is set to "Approved". D C185183 PQ/CMC Retest Date Classification Terminology C185186 Adequate Substance Process Understanding The applicant has appropriate process understanding to demonstrate that the quality of the subsequent API can be satisfactorily controlled. Adequate applies to substances only. Adequate The applicant has appropriate process understanding to demonstrate that the quality of the subsequent API can be satisfactorily controlled. Adequate applies to substances only. D C185183 PQ/CMC Retest Date Classification Terminology C185188 Proposed Substance Date Change For a Supplement that's changing the expiration date or the retest date that is already classified as "Approved" for the drug product or drug substance, the changed expiration date classification or retest date classification would be "Proposed". Proposed For a Supplement that's changing the expiration date or the retest date that is already classified as "Approved" for the drug product or drug substance, the changed expiration date classification or retest date classification would be "Proposed". D C185183 PQ/CMC Retest Date Classification 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. N C203777 PQ/CMC Ingredient Location Terminology C203881 Active Core Granule A granule core containing an active pharmaceuitcal ingredient (API) as opposed to the API being in the coating and not in the core. Active core/granulate The location of the ingredient of interest is within a starter core (granulate, bead or tablet) with no applied coating. N C203777 PQ/CMC Ingredient Location Terminology C203882 Extragranular Ingredient An ingredient that is added after granulation and located outside of the granule. Extragranular The location of the ingredient of interest is external to the granules (granulates) N C203777 PQ/CMC Ingredient Location Terminology C203883 Intragranular Ingredient An ingredient that is added before granulation and located within the granule. Intragranular The location of the ingredient of interest is within the granules (granulates) N C203778 PQ/CMC Release Profile Terminology C42669 Immediate Release Dosage Form A solid, semi-solid, solution or suspension that is designed to release its active and/or inert ingredient(s) upon administration with no enhanced, delayed or extended release effect. Immediate Release Profile A design in which no deliberate effort has been made to modify the API release rate. In the case of capsules and tablets, the inclusion or exclusion of a disintegrating agent is not interpreted as a modification. N C203778 PQ/CMC Release Profile Terminology C42713 Extended Release Dosage Form A solid, semi-solid, solution or suspension designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. Extended-Release Profile A design which makes the drug substance available over a prolonged period following administration, compared to that observed or anticipated for an immediate-release profile. N C203778 PQ/CMC Release Profile Terminology C42730 Delayed Release Dosage Form A solid, semi-solid, solution or suspension 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. Delayed-Release Profile A design which impedes release of the drug substance for some period of time after initial administration N C203778 PQ/CMC Release Profile 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. N C203779 PQ/CMC Coating Purpose Terminology C203884 Appearance Promoting Coating A coating applied to promote a particular appearance of a medication. Appearance/Identification A coating applied to achieve a specified presentation. N C203779 PQ/CMC Coating Purpose Terminology C203885 Consumption Promoting Coating A coating applied to promote consumption of a medication. Consumption Enhancement A coating applied to facilitate swallowing (e.g., making the tablet smoother, etc.). N C203779 PQ/CMC Coating Purpose Terminology C203886 Isolate Promoting Coating A coating applied to isolate one or more components of a medication. Content Isolation A coating applied to one or more components of a tablet (e.g., beads or granules) to mitigate interaction with other components. N C203779 PQ/CMC Coating Purpose Terminology C203887 Delayed Release Coating A coating applied to delay the release of the medication. Delayed Release A coating applied to achieve a delayed release profile. N C203779 PQ/CMC Coating Purpose Terminology C203888 Drug Layering Coating A coating applied to define a layer(s) within a medication. Drug Layering A coating applied to deposit API(s) on a product or component surface (i.e., tablet, bead, blend, or other intermediates). N C203779 PQ/CMC Coating Purpose Terminology C203889 Extended Release Coating A coating applied to extend the release of the medication. Extended Release A coating applied to achieve an extended-release profile. N C203779 PQ/CMC Coating Purpose Terminology C203890 Irritant Suppression Coating A coating applied to suppress drug-induced irritation. Irritant Suppression A coating applied to reduce dispersion within the GI tract (e.g., prevention of drug-induced irritation at a specific site such as NSAIDs with an enteric coating). N C203779 PQ/CMC Coating Purpose Terminology C203891 Odor Masking Coating A coating applied to mask an odor. Odor Masking A coating applied to obscure or enhance olfaction. N C203779 PQ/CMC Coating Purpose Terminology C203892 Protective Coating A coating applied to protect components of a medication. Protective A coating applied to ensure the properties of the contents are not impacted prior to administration (e.g., by moisture, air, light, handling, transportation, etc.) and/or after administration (e.g., by inactivation of drug in the stomach such as acid-labile APIs) N C203779 PQ/CMC Coating Purpose Terminology C203893 Seal Coating A coating applied to seal the contents of a medication. Seal A coating applied to improve drug product appearance, handling, and/or stability of the dosage form, but having no measurable effect on biopharmaceutical properties of the dosage form. N C203779 PQ/CMC Coating Purpose Terminology C203894 Site Delivery Coating A coating applied to ensure intended delivery site of medication. Site of Action A coating applied to ensure delivery of API to the site of action (e.g., colon delivery). N C203779 PQ/CMC Coating Purpose Terminology C203895 Taste Masking Coating A coating applied to mask the taste of a medication. Taste Masking A coating applied to obscure or enhance gustation. N C203780 PQ/CMC Product Part Type Terminology C202489 Dispersion Dosage Form A substance intended for administration as a dispersion. Dispersion A constituent in which particles are uniformly distributed throughout a liquid. N C203780 PQ/CMC Product Part Type Terminology C203896 Blended Dry Mixture A medication composed of a dry mixture of ingredients. Blend A constituent composed of a dry mixture of ingredients (e.g., API and/or excipients) mixed in pharmaceutical processing equipment. N C203780 PQ/CMC Product Part Type Terminology C203897 Capsule Shell The outer coating of a capsule. Capsule Shell An outer skin in which a medicinal substance is contained. N C203780 PQ/CMC Product Part Type Terminology C203898 Minitablet Dosage Form A dosage form composed of compressed tablets with a typical diameter of 1 to 4 mm. Minitablets can in turn be processed into various formulations and/or can be used in a composite dosing form for multiparticulate dosing. Minitablets A constituent composed of small tablets that are filled into capsules. N C203780 PQ/CMC Product Part Type Terminology C25450 Coat A thin outer layer or film covering something. Coating A constituent composed of a thin layer covering the outer surface. N C203780 PQ/CMC Product Part Type Terminology C42890 Bead Dosage Form A solid in the shape of a small sphere. Bead A constituent composed of small sphere(s). N C203780 PQ/CMC Product Part Type Terminology C42938 Granule Dosage Form A solid composed of small particles or grains. Granules A constituent composed of dry aggregates of powder particles that may contain one or more APIs, with or without other ingredients. N C203780 PQ/CMC Product Part Type 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 A constituent that is a clear, homogeneous liquid containing one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents. N C203780 PQ/CMC Product Part Type 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 A constituent prepared from powders or granules by compaction (with or without API and/or excipients). The tablet may be coated or uncoated. N C203780 PQ/CMC Product Part Type Terminology C66831 Layer A relatively thin sheetlike expanse or region lying over or under another. Layer A sheet, quantity, or thickness of material, typically one of several. C C176677 PQ/CMC Units of Measure Terminology C41127 Unified Atomic Mass Unit The non-SI unit of mass in terms of which the masses of individual atoms and molecules are expressed. Unified atomic mass unit is defined as one twelfth of the mass of an unbound atom of the carbon-12 nuclide, the predominant isotope of carbon, at rest and in its ground state. It is equal to 1.6606x10(E-27) kg (approximately). u Atomic Mass Unit || Dalton C C168624 PQ/CMC Organization-Site 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. C C168624 PQ/CMC Organization-Site 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. C C168624 PQ/CMC Organization-Site 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). C C168624 PQ/CMC Organization-Site Identifier Type Terminology C17998 Unknown Not known, observed, recorded; or reported as unknown by the data contributor. Unknown Not known, not observed, not recorded, or refused. C C133853 PQ/CMC Container Type Terminology C92708 Capsule A drug packaging type usually in a cylindrical shape with rounded ends. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid drug products. CAPSULE A drug packaging type usually in a cylindrical shape with rounded ends. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid drug products.