NCIt Subset Code NCIt Subset Preferred Term NCIt Concept Code NCIt Preferred Term NCIt Definition Stability Preferred Term Stability Definition C96071 Stability Study Data File Reason Terminology C115123 Abbreviated New Animal Drug Application Data submitted to an abbreviated new animal drug application. Abbreviated New Animal Drug Application Stability data submitted to an abbreviated (generic) new animal drug application. C96071 Stability Study Data File Reason Terminology C73113 Abbreviated New Drug Application Data submitted to an abbreviated new drug application. Abbreviated New Drug Application Stability data submitted to an abbreviated (generic) new human drug application. C96074 Stability Product Form Terminology C42887 Aerosol Dosage Form Contents packaged under pressure that are released upon activation of an appropriate valve system. Aerosol C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96081 Stability Container Type Terminology C43165 Ampule A container capable of being hermetically sealed, intended to hold sterile materials. Ampule C96071 Stability Study Data File Reason Terminology C96089 Annual Report Annual Report Stability data submitted to an annual report or update to an approved application. C96081 Stability Container Type Terminology C43166 Applicator A pre-filled non-injectable pipette, syringe or tube. Applicator C96081 Stability Container Type Terminology C43167 Bag A sac or pouch. Bag C96074 Stability Product Form Terminology C42892 Chewable Bar Dosage Form A bar designed to be chewed to release active and/or inert ingredient(s). Bar, Chewable C96074 Stability Product Form Terminology C42890 Bead Dosage Form A solid in the shape of a small sphere. Bead C96074 Stability Product Form Terminology C43451 Extended Release Bead Implant Dosage Form A solid in the shape of a small sphere intended to be embedded securely in the body and designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. Bead, Implant, Extended Release C96076 Stability Study Test Terminology C96100 Biological or Textual Reference to Actual Test or Parameter Biological Biological measurement or determination. C96071 Stability Study Data File Reason 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 Stability data submitted to a biologics license application. C96081 Stability Container Type Terminology C43168 Blister Pack A package that consists of molded plastic or laminate that has indentations (viewed as 'blisters' when flipped) into which a dosage form, is placed. A covering, usually of laminated material, is then sealed to the molded part. A strip pack is a specialized type of blister pack where there are no pre-formed or molded parts; in this case there are two flexible layers that are sealed with the dosage form in between. Suppositories that are strip packed between two layers of foil are also considered a blister pack. Blister Pack C96074 Stability Product Form Terminology C42891 Block Dosage Form A solid or semi-solid in the shape of a square or rectangle. Block C96081 Stability Container Type Terminology C43169 Bottle A vessel with a narrow neck designed to accept a specific closure. Bottle C96081 Stability Container Type Terminology C43170 Dispensing Bottle A bottle that is used by the pharmacist to dispense the prescribed medication. It includes preparations for which a dropper accompanies the bottle. Bottle, Dispensing C96081 Stability Container Type Terminology C43171 Dropper Bottle A bottle that has a device specifically intended for the application of a liquid in a drop by drop manner, or a device intended for the delivery of an exact dose (e.g., calibrated dropper for oral medications). Bottle, Dropper C96081 Stability Container Type Terminology C43172 Glass Bottle A glass vessel with a narrow neck designed to accept a specific closure. Bottle, Glass C96081 Stability Container Type Terminology C43173 Plastic Bottle A plastic vessel with a narrow neck designed to accept a specific closure. Bottle, Plastic C96081 Stability Container Type Terminology C43174 Pump Bottle A bottle that is fitted with a pumping mechanism for the administration of drug product. Bottle, Pump C96081 Stability Container Type Terminology C43175 Spray Bottle A bottle that is fitted with an atomizer or a device which produces finely divided liquid carried by air. Bottle, Spray C96081 Stability Container Type Terminology C43176 Unit Dose Bottle A bottle that contains a single whole dose of a non-parenteral drug product. Bottle, Unit-Dose C96081 Stability Container Type Terminology C43177 Applicator Bottle A bottle which includes a device for applying its contents. Bottle, with Applicator C96081 Stability Container Type Terminology C43178 Box A square or rectangular vessel, usually made of cardboard or plastic. Box C96081 Stability Container Type Terminology C43179 Unit Dose Box A box that contains a single dose of a non-parenteral drug product. [Note: Boxes that contain 100 unit dose blister packs should be classified under blister pack, since this is the immediate container into which the dosage form is placed.] Box, Unit-Dose C96081 Stability Container Type Terminology C43180 Can A cylindrical vessel, usually made of metal. Can C96081 Stability Container Type Terminology C43181 Canister A type of can for holding a drug product. Canister C96081 Stability Container Type Terminology C96143 Lined Canister A round container that has an inner layer of a material different from what the canister is composed of. Canisters, lined A type of lined can for holding a drug product. C96074 Stability Product Form Terminology C25158 Capsule Dosage Form A solid contained within either a hard or soft soluble shell, usually prepared from gelatin. Capsule C96074 Stability Product Form Terminology C42895 Coated Capsule Dosage Form A capsule that contains an additional outer layer over the capsule shell. Capsule, Coated C96074 Stability Product Form Terminology C42896 Coated Pellet in Capsule Dosage Form A capsule composed of small globular masses covered with an outer shell. Capsule, Coated Pellets C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product Form Terminology C42936 Gelatin Coated Capsule Dosage Form A capsule covered with a thin layer of gelatin. Capsule, Gelatin Coated C96074 Stability Product 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 C96081 Stability 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-Container C96081 Stability Container Type Terminology C43182 Carton A cardboard box or container which is usually considered a secondary packaging component. Carton C96081 Stability Container Type Terminology C43183 Cartridge A container consisting of a cylinder with a septum at one end, and a seal at the other end, which is inserted into a device to form a syringe which contains a single dose of a parenteral drug product. Cartridge C96081 Stability Container Type Terminology C43184 Packaging Case A receptacle for holding something (e.g., that into which some oral contraceptive blister packs are placed). Case C96081 Stability Container Type Terminology C43185 Cello Pack A plastic 'clamshell' [thin plastic pre-formed structure for a device]. Cello Pack C96074 Stability Product Form Terminology C45414 Cement Dosage Form A base composed of bonding agents intermingled with active and/or inert ingredient(s), which rapidly hardens into a firm mass upon application. Cement C96077 Stability Study Method Type Terminology C96164 Code of Federal Regulations Method A method described in the Code of Federal Regulations. CFR Regulation Method dictated by CFR. C96076 Stability Study Test Terminology C96099 Chemical or Textual Reference to Actual Test or Parameter Chemical Chemical measurement or determination. C96080 Stability Container Closure System Terminology C96113 Child Resistant Metal Container Closure Metal closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly. Child-resistant, Metal Metal closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly. C96080 Stability Container Closure System Terminology C96114 Child Resistant Plastic Container Closure Plastic closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly. Child-resistant, Plastic Plastic closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly. C96074 Stability Product Form Terminology C42678 Cigarette Dosage Form A solid composed of active and/or inert ingredient(s) wrapped in a paper cylinder whereby one end is burned. The ingredient is released in a smoke form, which is inhaled. Cigarette C96079 Stability Study Type Terminology C96111 Clinical Lot Clinical Stability data for a clinical lot. C96074 Stability Product Form Terminology C60884 Cloth Dosage Form A solid composed active and/or inert ingredient(s) in a woven absorbent material. Cloth C96079 Stability Study Type Terminology C96109 Commercial Lot Commercial Stability data for a commercial lot. C96077 Stability Study Method Type Terminology C96102 Compendial Method Standardized methods and specification testing for generic pharmaceutical raw materials and finished products. Compendial Official compendial method. C96074 Stability Product 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 C96074 Stability Product Form Terminology C42900 Cone Dosage Form A solid with a shape bounded by a circular base converging upon a single vertex. Cone C96081 Stability Container Type Terminology C43186 Container An object that can be used to hold things. Container C96080 Stability Container Closure System Terminology C96115 Continuous Thread Metal Container Closure Metal closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal. Continuous Thread, Metal Metal closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal. C96080 Stability Container Closure System Terminology C96116 Continuous Thread Plastic Container Closure Plastic closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal. Continuous Thread, Plastic Plastic closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal. C96074 Stability Product Form Terminology C42919 Extended Release Core Dosage Form A solid or liquid core composed of active and/or inert ingredient(s) enclosed by a polymer coated shell. It is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. Core, Extended Release C96074 Stability Product Form Terminology C28944 Cream Dosage Form A semi-solid composed of an emulsion of lipids, hydrocarbons, waxes, or polyols in water. Cream C96074 Stability Product 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 C96080 Stability Container Closure System Terminology C96125 Crown Metal Container Closure A non-threaded shallow draw metal closure that normally has 21 corrugations on the outer edge, which function to engage the container when applied. The crown is only 1/4" high when manufactured and does not have a rolled edge or wire. The crown is manufactured 26mm worldwide and can be applied to either a threaded finish or a solid ring pry-off finish. Crown, Metal A non-threaded shallow draw metal closure that normally has 21 corrugations on the outer edge, which function to engage the container when applied. The crown is only 1/4" high when manufactured and does not have a rolled edge or wire. The crown is manufactured in 26mm worldwide and can be applied to either a threaded finish or a solid ring pry-off finish. C96074 Stability Product 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 C96081 Stability Container Type Terminology C43187 Cup A bowl-shaped container. Cup C96081 Stability Container Type Terminology C43188 Unit Dose Cup A cup intended to hold a single dose of a non-parenteral drug product. Cup, Unit-Dose C96070 Stability Study Data File Type Terminology C103853 Cycled Drug Stability Study-Complex Cycled-Complex A complex Cycled study requiring multiple files to describe the conditions. C96070 Stability Study Data File Type Terminology C96086 Cycled Drug Stability Study-Simple Cycled-Simple A simple Cycled study requiring one file to describe the conditions. C96081 Stability Container Type Terminology C43189 Gas Cylinder A container designed specifically to hold gases. Cylinder C96083 Stability Study Pause Description Terminology C96151 Delayed Testing Delayed Sample is not tested immediately. C96083 Stability Study Pause Description Terminology C96154 Ambient Delayed Testing Delayed, Ambient Sample is stored at ambient conditions and not tested immediately. C96083 Stability Study Pause Description Terminology C96153 Frozen Delayed Testing Delayed, Frozen Sample is frozen and not tested immediately. C96083 Stability Study Pause Description Terminology C96155 Refrigerated Delayed Testing Delayed, Refrigerate Sample is refrigerated and not tested immediately. C96079 Stability Study Type Terminology C96110 Development Lot Development Stability data for a developmental lot. C96081 Stability Container Type Terminology C43190 Dewar A container, usually made of glass or metal, that has at least two walls with the space between each wall evacuated so as to prevent the transfer of heat. The inside of the container often has a coating (as silvering) on the inside to reduce heat transfer, and is used especially for storing liquified gases or for experiments at low temperatures. The size can vary from that of a small thermos bottle up to that which may be mounted upon a large truck (also known as a 'cryogenic truck'). Dewar C96081 Stability Container Type Terminology C43191 Dialpack A dose pack container designed to assist with patient compliance. The patient turns a dial to the correct day and the correct dose is made available and the container indicates that the dose has been removed. Dialpack C96074 Stability Product Form Terminology C47890 Vaginal Diaphragm Dosage Form A dome-shaped insert with a springy, flexible rim intended to be inserted into the vagina and positioned behind the pelvic bone to completely cover the cervix. Diaphragm C96074 Stability Product 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 C96081 Stability Container Type Terminology C96141 Petri Dish A shallow dish with a lid used to culture cells. Dish, Petri A shallow dish with a loose-fitting cover. C96081 Stability Container Type Terminology C43192 Dose Pack A container in which a preselected dose or dose regimen of the medication is placed. Dose Pack C96074 Stability Product Form Terminology C42679 Douche Dosage Form A substance intended for use as a vaginal irrigant. Douch C96074 Stability Product Form Terminology C42763 Dressing Dosage Form A substance intended for administration in or on a wound. Dressing C96074 Stability Product 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 C96081 Stability Container Type Terminology C43193 Packaging Drum A straight-sided cylindrical shipping container with flat ends; one of which can be opened/closed. Drum C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product Form Terminology C42915 Enema Dosage Form A solution or suspension intended for administration into the rectum. Enema C96074 Stability Product 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 C96078 Stability Study Interpretation Terminology C44281 Failed Having undergone failure; did not accomplish the intended purpose. Failed This is equivalent to does not meet requirements or specifications. C96074 Stability Product 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 C96074 Stability Product Form Terminology C42932 Film Dosage Form A thin layer of water soluble or insoluble polymer intended to coat the site of administration. Film C96074 Stability Product 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 C96074 Stability Product Form Terminology C42984 Soluble Film Dosage Form A film that will dissolve in a liquid solvent to form a solution. Film, Soluble C96081 Stability Container Type Terminology C96144 Flask A container with a base wider than the narrow neck traditionally used for holding liquids. Flask Flat bottom bottle, container or vessel. C96081 Stability Container Type Terminology C79135 Flexible Intermediate Bulk Container A receptacle with a body constructed of film, woven plastic, woven fabric, paper or combination thereof, together with any appropriate service equipment and handling devices, and if necessary, an inner coating or liner. Flexible Intermediate Bulk Container C96080 Stability Container Closure System Terminology C96128 Flip-Top Dispensing Plastic Container Closure A hinged single or dual flap closure for controlled product dispensing. Flip-Top (Dispensing), Plastic A hinged single or dual flap closure for controlled product dispensing. C96074 Stability Product Form Terminology C60927 Dosage Form for Solution A substance intended for administration as a solution. For Solution C96074 Stability Product Form Terminology C60928 Dosage Form for Suspension A substance intended for administration as a suspension. For Suspension C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product Form Terminology C48193 Generator Dosage Form An apparatus that converts solutions, suspensions or solids, composed of active and/or inert ingredient(s) into a vapor or gas by heat or chemical reaction. Generator C96071 Stability Study Data File Reason Terminology C115122 Generic Investigational New Animal Drug File Data submitted to a generic investigational new animal drug file. Generic Investigational New Animal Drug File Stability data submitted to a generic investigational new animal drug file. C96074 Stability Product 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 C96074 Stability Product Form Terminology C45416 Graft Dosage Form A solid composed of a piece of skin or other tissue intended for implantation into or on the body. Graft C96074 Stability Product Form Terminology C42938 Granule Dosage Form A solid composed of small particles or grains. Granule C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product Form Terminology C42939 Granule for Solution Dosage Form A granule intended for administration as a solution. Granule, for Solution C96074 Stability Product Form Terminology C42940 Granule for Suspension Dosage Form A granule intended for administration as a suspension. Granule, for Suspension C96074 Stability Product 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 C96074 Stability Product Form Terminology C42941 Gum Dosage Form A semi-solid composed of a sticky, mucilaginous polysaccharide. Gum C96074 Stability Product 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 C96074 Stability Product Form Terminology C42978 Resin Gum Dosage Form A semi-solid composed of a mixture of gum and a plant based hydrocarbon. Gum, Resin C96080 Stability Container Closure System Terminology C96129 Hinged Dispensing Plastic Container Closure A closure with a lid that is hinged to the top of a closure and opens to expose a dispensing orifice. Hinged (Dispensing), Plastic A closure with a lid that is hinged to the top of a closure and opens to expose a dispensing orifice. C96071 Stability Study Data File Reason 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) Stability data submitted for an HDE application. C96082 Stability Study Storage Condition Terminology C96146 ICH Temperature/Humidity Storage Condition ICH ICH storage temperature, Q1A-Q1F. C96083 Stability Study Pause Description Terminology C96150 Immediate Testing Immediate Sample is tested immediately. C96074 Stability Product Form Terminology C42942 Implant Dosage Form A solid intended for insertion securely within the body. Implant C96074 Stability Product Form Terminology C42944 Inhalant Dosage Form Vaporized active and/or inert ingredient(s) intended for administration by inhalation. Inhalant C96081 Stability Container Type Terminology C16738 Inhaler A device by means of which a medicinal product can be administered by inspiration through the nose or the mouth. Inhaler C96081 Stability Container Type Terminology C43194 Inhaler Refill A container of medication intended to refill an inhaler. Inhaler, Refill C96074 Stability Product 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 C96074 Stability Product Form Terminology C42946 Injectable Dosage Form A substance intended for injection. Injection C96074 Stability Product Form Terminology C42914 Emulsion for Injection Dosage Form An emulsion intended for injection. Injection, Emulsion C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product Form Terminology C42974 Powder for Injectable Solution Dosage Form A powder intended for injection following reconstitution to form a solution. Injection, Powder, for Solution C96074 Stability Product Form Terminology C42976 Powder for Injectable Suspension Dosage Form A powder intended for injection following reconstitution to form a suspension. Injection, Powder, for Suspension C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product Form Terminology C42945 Injectable Solution Dosage Form A solution intended for injection. Injection, Solution C96074 Stability Product Form Terminology C42899 Concentrated Injectable Solution Dosage Form A concentrate which is usually diluted prior to administration by injection. Injection, Solution, Concentrate C96074 Stability Product Form Terminology C42995 Injectable Suspension Dosage Form A suspension intended for injection. Injection, Suspension C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product Form Terminology C60933 Insert Dosage Form A solid or semi-solid intended for administration within the body. Insert C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96071 Stability Study Data File Reason 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 Stability data submitted to an investigational device exemption. C96071 Stability Study Data File Reason Terminology C96091 Investigational New Animal Drug File Investigational New Animal Drug File Stability data submitted to an investigational new animal drug file. C96071 Stability Study Data File Reason Terminology C96090 Investigational New Drug Application Investigational New Drug Application Stability data submitted to an investigational new human drug application. C96074 Stability Product Form Terminology C42947 Irrigant Dosage Form A solution or suspension used to bathe or flush open wounds or body cavities. Irrigant C96081 Stability Container Type Terminology C43195 Jar A rigid container having a wide mouth and often no neck which typically holds solid or semisolid drug products. Jar C96074 Stability Product 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 C96081 Stability Container Type Terminology C43196 Jug A large, deep container that has a narrow mouth, is typically fitted with a handle, and is used to hold liquids. Jug C96081 Stability Container Type Terminology C43197 Drug Kit A packaged set of related pharmaceutical or and/or drug delivery devices used for a particular medical activity or procedure including required documentation for kit components and the entire kit. Kit C96074 Stability Product Form Terminology C47916 Kit Dosage Form A collection of unrelated materials that are used together to orchestrate dosage administration. Kit C96074 Stability Product Form Terminology C45413 Dental Liner Dosage Form A resinous film-forming agent dissolved in a solvent or a calcium hydroxide suspension within a synthetic resin solution, which rapidly hardens into a firm mass upon administration. Liner, Dental C96080 Stability Container Closure System Terminology C96130 Linerless Plastic Container Closure A closure that incorporates a specific molded-in feature such as rings, plugs or flexible sections. These features achieve a seal by conforming to one or more of the sealing surfaces on the container neck finish. Linerless, Plastic A closure that incorporates a specific molded-in feature such as rings, plugs or flexible sections. These features achieve a seal by conforming to one or more of the sealing surfaces on the container neck finish. C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product Form Terminology C42953 Liquid Dosage Form A substance in the fluid state of matter having no fixed shape but a fixed volume. Liquid C96074 Stability Product 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 C96074 Stability Product Form Terminology C29167 Lotion Dosage Form A semi-solid composed of an oil in water emulsion, with lower viscosity than cream or gel. Lotion C96074 Stability Product 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 C96074 Stability Product Form Terminology C60958 Lotion Shampoo Dosage Form A lotion composed of anionic surfactant intended for administration to the hair or scalp. Lotion/Shampoo C96074 Stability Product 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 C96078 Stability Study Interpretation 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 The value should not be greater than the given value excluding the given value, which is equivalent to "less than". C96080 Stability Container Closure System Terminology C96126 Lug Metal Container Closure Closure with an ability to be applied and removed with a partial turn. The closure can also be produced with vacuum buttons that can clearly indicate to the packer if a vacuum has been effectively drawn following the closure application. Lug, Metal Closure with an ability to be applied and removed with a partial turn. The closure can also be produced with vacuum buttons that can clearly indicate to the packer if a vacuum has been effectively drawn following the closure application. C96074 Stability Product 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 C96078 Stability Study Interpretation 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 The value should not be smaller than the given value excluding the given value, which is equivalent to "greater than". C96078 Stability Study Interpretation Terminology C48660 Not Applicable Determination of a value is not relevant in the current context. NA If a value for test has to be provided, but has no given criteria (e.g., the result is for "report only" or "monitoring"). C96071 Stability Study Data File Reason Terminology C96092 New Active Ingredient New Active Ingredient Stability data submitted for an active ingredient, could be stability data for an active ingredient submitted in a drug application, or a Master File. C96071 Stability Study Data File Reason Terminology C72901 New Animal Drug Application New Animal Drug Application Stability data submitted to a new animal drug application. C96071 Stability Study Data File Reason 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 Stability data submitted to a new human drug application. C96078 Stability Study Interpretation 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 The value should not be smaller than the given value and includes the given value, which is equivalent to "greater than or equal to". C96078 Stability Study Interpretation 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 The value should not be greater than the given value and includes the given value, which is equivalent to "less than or equal to". C96074 Stability Product Form Terminology C48624 Dosage Form Not Applicable An indication that the dosage form is not relevant or appropriate. Not Applicable C96081 Stability Container Type Terminology C48626 Package Type Not Stated The package type is not stated or is unavailable. Not Stated C96074 Stability Product Form Terminology C42965 Oil Dosage Form A solution or suspension that is hydrophobic, soluble in organic solvents, and liquid at ambient temperature. Oil C96074 Stability Product 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 C96074 Stability Product 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 C96081 Stability Container Type Terminology C43233 Drug Package The drug product container with any accompanying materials or components. This may include the protective packaging, labeling, administration devices, etc. Package C96081 Stability Container Type Terminology C43198 Combination Package A package in which two or more drug products that are normally available separately are now available together. Package, Combination C96081 Stability Container Type Terminology C43199 Packet An envelope into which only one dose of a drug product, usually in the form of granules or powder, has been directly placed. An example includes glassine powder paper containing aspirin. Other examples include aluminum foil packets into which alcohol swabs and pledgets are placed. Packet C96074 Stability Product Form Terminology C47887 Packing Dosage Form A solid composed of a material that contains active and/or inert ingredient(s) which is intended to be placed in a cavity or depression within the body. Packing C96081 Stability Container Type Terminology C79136 Pail A watertight vessel, often cylindrical, that is usually fitted with a handle, and that may have a lid. Pail C96078 Stability Study Interpretation Terminology C81275 Pass One of two possible results of a pass/fail assessment; when the result satisfies a condition. Passed This is equivalent to meets requirements or specifications. C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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, Electrically Controlled C96081 Stability Container Type Terminology C82332 Patch A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. Patch-Container C96074 Stability Product 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 C96074 Stability Product Form Terminology C42943 Implantable Pellet Dosage Form A pellet intended for insertion securely within the body. Pellet, Implantable C96074 Stability Product 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 C96074 Stability Product Form Terminology C87542 Pendant Dosage Form A pharmaceutical dosage form containing active substance(s) delivered via pendant. Pendant C96070 Stability Study Data File Type Terminology C96087 Photostability Drug Study A study conducted to determine the extent of effect that exposure to light has on a pharmaceutical product. Photostability A Photostability study would be a one time study. C96076 Stability Study Test Terminology C96098 Physical or Textual Reference to Actual Test or Parameter Physical Physical measurement or determination. C96074 Stability Product Form Terminology C25394 Pill Dosage Form A solid composed of a small, round object composed of active and/or inert ingredient(s). Pill C96074 Stability Product 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 C96081 Stability Container Type Terminology C96142 Microwell Plate A flat dish type device with multiple wells for testing cellular material. Plate, Microwell Small volume multi-chambered plate (e.g. 96 well). C96081 Stability Container Type Terminology C43200 Pouch A flexible container used to protect or hold one or more doses of a drug product (e.g. a pouch into which oral contraceptive blister packs are inserted, and an overwrap pouch for large volume parenterals). Pouch C96074 Stability Product 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 C96074 Stability Product Form Terminology C42972 Powder Dosage Form A solid composed of a mixture of dry, finely divided active and/or inert ingredient(s). Powder C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product Form Terminology C42973 Powder for Solution Dosage Form A powder that yields a solution following reconstitution with an appropriate liquid. Powder, for Solution C96074 Stability Product Form Terminology C42975 Powder for Suspension Dosage Form A powder that forms a suspension when reconstituted with a liquid solution. Powder, for Suspension C96074 Stability Product Form Terminology C87541 Lyophilized Powder Dosage Form A pharmaceutical dosage form comprised of lyophilized powder. Powder, Lyophilized C96074 Stability Product 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 C96071 Stability Study Data File Reason Terminology C70880 Premarket Approval Application Premarket Approval Stability data submitted for a PMA application. C96071 Stability Study Data File Reason 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) Stability data submitted for a premarket 510(k) submission. C96080 Stability Container Closure System Terminology C96124 Press-On Composite Container Closure A metal/plastic composite cap composed of a plastisol lined metal disk, assembled to a plastic band. The closure requires a simple glass bead finish common on bowls, tumblers and carafes. Press-on, Composite A metal/plastic composite cap composed of a plastisol lined metal disk, assembled to a plastic band. The closure requires a simple glass bead finish common on bowls, tumblers and carafes. C96080 Stability Container Closure System Terminology C96123 Press-On / Twist-Off Metal Container Closure Closure with a stepped, skirted drawn shell with an inside curl. The closure is lined with an annular plastisol material designed to provide a proper seal along the top and side surfaces of the glass container finish. The closure uses a special plastisol material that, following application, takes a permanent impression of the glass threads ensuring cam-off and reseal. Press-on/twist-off, Metal Closure with a stepped, skirted drawn shell with an inside curl. The closure is lined with an annular plastisol material designed to provide a proper seal along the top and side surfaces of the glass container finish. The closure uses a special plastisol material that, following application, takes a permanent impression of the glass threads ensuring cam-off and reseal. C96077 Stability Study Method Type 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 Company method. C96082 Stability Study Storage Condition Terminology C96148 Proprietary Storage Condition Storage conditions according to protocols set by a business or company. Proprietary Company defined. C96080 Stability Container Closure System Terminology C96131 Pump Dispensing Plastic Container Closure Closure dispensing pumps are used to dispense product from containers. Pump (Dispensing), Plastic Closure dispensing pumps are used to dispense product from containers. C96080 Stability Container Closure System Terminology C96132 Push-Pull Dispensing Plastic Container Closure A two-piece dispensing closure that includes a base member the lower portion of which is designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. The spout member may be moved upward and downward to open and close the dispensing passageway. Push-pull (Dispensing), Plastic A two-piece dispensing closure that includes a base member the lower portion of which is designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. The spout member may be moved upward and downward to open and close the dispensing passageway. C96074 Stability Product Form Terminology C60988 Ring Dosage Form A solid composed active and/or inert ingredient(s) of in the shape of a hoop. Ring C96074 Stability Product Form Terminology C42979 Rinse Dosage Form A solution or suspension intended for irrigation purposes. Rinse C96080 Stability Container Closure System Terminology C96127 Roll On Metal Container Closure A tamper-evident closure produced as an unthreaded shell containing a liner. It is applied to the proper finish on a plastic or glass container by the bottler, using a roll-on capping machine that forms a thread in the closure matching the bottle thread. Roll-on, Metal A tamper-evident closure produced as an unthreaded shell containing a liner. It is applied to the proper finish on a plastic or glass container by the bottler, using a roll-on capping machine that forms a thread in the closure matching the bottle thread. C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product Form Terminology C87537 Smoke Paper Dosage Form A pharmaceutical dosage form in paper; when lit, it delivers medicated smoke. Smoke Paper C96074 Stability Product 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 C96080 Stability Container Closure System Terminology C96133 Snap-On Cap Plastic Container Closure A non-threaded closure that is pressed onto the package finish with a protruding feature that mates with a similar protruding feature on the closure to secure the closure to the package. Snap-on Cap, Plastic A non-threaded closure that is pressed onto the package finish with a protruding feature that mates with a similar protruding feature on the closure to secure the closure to the package. C96080 Stability Container Closure System Terminology C96134 Snip-Tip Dispensing Plastic Container Closure Conical closure that is turned onto a container. The tip is cut off to open the container. Snip-tip (Dispensing), Plastic Conical closure that is turned onto a container. The tip is cut off to open the container. C96074 Stability Product Form Terminology C42983 Soap Dosage Form An anionic surfactant for cleansing. Soap C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product Form Terminology C60992 Drop Solution Dosage Form A solution intended for administration in a drop-wise fashion. Solution/Drops C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product Form Terminology C42990 Spray Suspension Dosage Form A spray composed of a suspension that contains active and/or inert ingredient(s). Spray, Suspension C96069 Stability Data Standards Terminology C96080 Stability Container Closure System Terminology Terminology developed to support Closure Systems within the Stability Data Standards. Stability Container Closure System Terminology The closure system of the container. C96069 Stability Data Standards Terminology C96081 Stability Container Type Terminology Terminology developed to support Container Types within the Stability Data Standards. Stability Container Type Terminology As reported entity or as part of a reported packaged product, this is the official code for a referenced package type. For FDA implementation, only the display Name (i.e., the product name is mandatory, the code values might be provided if available). C96069 Stability Data Standards Terminology C96074 Stability Product Form Terminology Terminology developed to support Product Forms within the Stability Data Standards. Stability Product Form Terminology This code describes the form of the reported product. Code values might be provided if available (e.g., when used in other submissions like SPL). C96069 Stability Data Standards Terminology C96072 Stability Product Identifier Terminology Terminology developed to support Product Identifiers within the Stability Data Standards. Stability Product Identifier Terminology This is the code for the official product name. For FDA implementation, only the "displayName" (i.e., the product name) is mandatory, the code values might be provided if available (e.g., when used in other submissions like SPL). For NDA this is a new identifier. For ongoing studies the identifier should be identical to an already submitted code, so that a unique relationship can be established. C96069 Stability Data Standards Terminology C96071 Stability Study Data File Reason Terminology Terminology developed to support Data File Reasons within the Stability Data Standards. Stability Study Data File Reason Terminology This code should indicate the type of application the data supports or whether the data is submitted to an existing application. The codes indicate that the data is part of an Annual Report, New Drug Application, New Active Ingredient, Biologics License Application, Premarket Approval, or Supplement to an Approved Application. C96069 Stability Data Standards Terminology C96070 Stability Study Data File Type Terminology Terminology developed to support Data File Types within the Stability Data Standards. Stability Study Data File Type Terminology This code should reflect if the file in hand is a standard data file for one storage condition or a partial file as part of a cycled study. C96069 Stability Data Standards Terminology C96078 Stability Study Interpretation Terminology Terminology developed to support Study Interpretations within the Stability Data Standards. Stability Study Interpretation Terminology For a single acceptance criterion (i.e., limit) this code describes how to relate the given value to a measured value, (e.g., a result should not be greater (not more) than the given value). The common accepted nomenclature should be used here. C96069 Stability Data Standards Terminology C96077 Stability Study Method Type Terminology Terminology developed to support Study Method Types within the Stability Data Standards. Stability Study Method Type Terminology A classification of the methods used in stability testing. C96069 Stability Data Standards Terminology C96083 Stability Study Pause Description Terminology Terminology developed to support Pause Descriptions within the Stability Data Standards. Stability Study Pause Description Terminology This code describes any delay that happened during testing, e.g. none (Immediate) or freeze sample (Delayed Frozen). C96069 Stability Data Standards Terminology C96082 Stability Study Storage Condition Terminology Terminology developed to support Storage Conditions within the Stability Data Standards. Stability Study Storage Condition Terminology The code provided represents a storage condition. Dependent of the internal company definitions this condition might be simple (e.g., 25 degrees) or complex (e.g., 25 degrees C/60% R.H. upright). C96069 Stability Data Standards Terminology C96076 Stability Study Test Terminology Terminology developed to support Study Tests within the Stability Data Standards. Stability Study Test Terminology This code describes the test performed during a study within the specification sheet. C96069 Stability Data Standards Terminology C96079 Stability Study Type Terminology Terminology developed to support Study Types within the Stability Data Standards. Stability Study Type Terminology This code classifies the type of study performed on the given Research Subject, e.g., Commercial, Development, Clinical. C96069 Stability Data Standards Terminology C96075 Stability Substance Identifier Terminology Terminology developed to support Substance Identifiers within the Stability Data Standards. Stability Substance Identifier Terminology The official code for a referenced substance (e.g., acetylsalicylic acid), as a single entity or part of a product (e.g., aspirin). For FDA implementation, only the displayName (i.e. the product name) is mandatory, the code values might be provided if available (e.g., when used in other submissions like SPL), please refer to Substance Registration System - Unique Ingredient Identifier (UNII), at http://www.fda.gov/oc/datacouncil/spl.html. If you have a new compound that is not in the Substance Registration System (SRS) it can be registered by contacting fda-srs(at)fda.hhs.gov. The compound can be given a code and the other information about the compound can remain confidential. C96070 Stability Study Data File Type Terminology C96085 Standard Drug Stability Study Standard A Standard stability study would be a long term or accelerated stability study for either a finished product or active ingredient. C96074 Stability Product Form Terminology C42991 Stick Dosage Form A solid composed active and/or inert ingredient(s) in a long, slender cylindrical shape. Stick C96080 Stability Container Closure System Terminology C96139 Stopper Container Closure Object used to plug opening of container. Stopper Object used to plug opening of container. C96074 Stability Product Form Terminology C47914 Strip Dosage Form A solid composed of active and/or inert ingredient(s) in a long narrow piece of material. Strip C96081 Stability Container Type Terminology C43201 Supersack A multilayer paper bag for shipping some solid bulk excipients, usually in the form of powder or granules. Supersack C96071 Stability Study Data File Reason Terminology C96094 Approved Application Supplement Supplement to an Approved Application Stability data submitted to an approved application already filed with the FDA. C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product Form Terminology C42994 Suspension Dosage Form Insoluble solid particles composed of active and/or inert ingredient(s) that are dispersed in a liquid. Suspension C96074 Stability Product 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 C96074 Stability Product Form Terminology C60995 Drop Suspension Dosage Form A suspension intended for administration in a drop-wise fashion. Suspension/Drops C96074 Stability Product Form Terminology C47889 Suture Dosage Form A solid composed of fibrous strands of material that are used to bind wound edges together. Suture C96074 Stability Product 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 C96081 Stability Container Type Terminology C43202 Syringe A device for the administration of drug products that consists of a rigid barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate. Syringe C96081 Stability Container Type Terminology C43203 Glass Syringe A device for the administration of parenteral drug products that consists of a rigid glass barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate. Syringe, Glass C96081 Stability Container Type Terminology C43204 Plastic Syringe A device for the administration of parenteral drug products that consists of a rigid plastic barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate. Syringe, Plastic C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product Form Terminology C42893 Chewable Tablet Dosage Form A tablet that must be chewed to release the active and/or inert ingredient(s). Tablet, Chewable C96074 Stability Product Form Terminology C42897 Coated Tablet Dosage Form A tablet whose outer shell is covered with a substance. Tablet, Coated C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product Form Terminology C42931 Film Coated Tablet Dosage Form A tablet covered with a thin layer of water soluble or insoluble polymer. Tablet, Film Coated C96074 Stability Product 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 C96074 Stability Product Form Terminology C61004 Tablet for Solution Dosage Form A tablet that changes into a solution when added to a liquid solvent. Tablet, for Solution C96074 Stability Product Form Terminology C61005 Tablet for Suspension Dosage Form A tablet that changes into a suspension when added to a liquid solution. Tablet, for Suspension C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product 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 C96074 Stability Product Form Terminology C42985 Soluble Tablet Dosage Form A tablet that will dissolve in a liquid solvent to form a solution. Tablet, Soluble C96074 Stability Product Form Terminology C42992 Sugar Coated Tablet Dosage Form A tablet covered with sugar. Tablet, Sugar Coated C96081 Stability Container Type Terminology C43205 Tabminder A specialized package; it registers each time it is opened and is used for checking patient compliance to prescribed medication regimens. Tabminder C96074 Stability Product Form Terminology C87539 Tag Dosage Form A pharmaceutical dosage form containing active substance(s) that are delivered via a tag device. Tag C96080 Stability Container Closure System Terminology C96120 Tamper Evident Composite Container Closure Composite tamper-evident closures usually consist of a metal disk with a plastic skirt. The plastic skirt is perforated or weakened in some manner so that when the closure is removed, this section is designed to break and either remain on the container or attached to the closure to indicate the package has been opened. Tamper-evident, Composite Composite tamper-evident closures usually consist of a metal disk with a plastic skirt. The plastic skirt is perforated or weakened in some manner so that when the closure is removed, this section is designed to break and either remain on the container or attached to the closure to indicate the package has been opened. C96080 Stability Container Closure System Terminology C96117 Tamper Evident Metal Container Closure A closure/finish of a closure/container system designed to make it difficult to achieve the first removal of a closure from a container without it being detectable by subsequent users that the package seal has been breached (e.g., aluminum overseal). Tamper-evident, Metal A closure/finish of a closure/container system designed to make it difficult to achieve the first removal of a closure from a container without it being detectable by subsequent users that the package seal has been breached (e.g., aluminum overseal). C96080 Stability Container Closure System Terminology C96118 Tamper Evident Plastic Container Closure A closure that shows the package has been opened and the product has been exposed to the outside environment. Tamper-evident, Plastic A closure that shows the package has been opened and the product has been exposed to the outside environment. C96074 Stability Product Form Terminology C47892 Tampon Dosage Form A solid composed of a plug made from absorbent material. Tampon C96081 Stability Container Type Terminology C43206 Packaging Tank A large receptacle used for holding, transporting, or storing liquids or gases, and often referred to as a reservoir. Tank C96074 Stability Product 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 C96080 Stability Container Closure System Terminology C96140 Tie Container Closure Line, ribbon, or cord used for fastening, or drawing the container closed. Tie Line, ribbon, or cord used for fastening, or drawing the container closed. C96074 Stability Product Form Terminology C43000 Tincture Dosage Form A solution composed of an alcoholic extract or solution of nonvolatile active and/or inert ingredient(s). Tincture C96080 Stability Container Closure System Terminology C96135 Toggle-Swing Dispensing Plastic Container Closure A closure with a lower part attaches securely and seals the container. The upper part provides a second movable portion which functions in a rocker-like pivotal motion between an open and a closed position. Toggle-swing (Dispensing), Plastic A closure with a lower part attaches securely and seals the container. The upper part provides a second movable portion which functions in a rocker-like pivotal motion between an open and a closed position. C96081 Stability Container Type Terminology C53438 Tray A shallow flat receptacle, with a raised edge or rim, used for carrying, holding, or displaying finished drug product in its primary or market package. A tray and its contents may be encased in shrink-wrapped plastic for shipping, or with a cover or an overwrap as part of a unit of use package or kit. Tray C96080 Stability Container Closure System Terminology C96136 Trigger Spray Dispensing Plastic Container Closure Closure designed to dispense product from containers by spraying the product when a trigger is pulled. Trigger Sprayer (Dispensing), Plastic Closure designed to dispense product from containers by spraying the product when a trigger is pulled. C96074 Stability Product 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 C96081 Stability Container Type Terminology C42794 Packaging Tube A flexible container for semisolid drug products which is flattened and crimped or sealed at one end and has a reclosable opening at the other. Tube C96081 Stability Container Type Terminology C43207 Applicator Tube A tube which is provided with a device (the applicator) for administering the dosage form. The applicator may be part of the tube closure or be separate. Tube, with Applicator C96080 Stability Container Closure System Terminology C96137 Twist Open/Close Dispensing Plastic Container Closure Two-piece dispensing closure that has a lower portion designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. Rotating the spout member opens and closed the container. Twist Open/Close (Dispensing), Plastic Two-piece dispensing closure that has a lower portion designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. Rotating the spout member opens and closed the container. C96074 Stability Product Form Terminology C43002 Unassigned Dosage Form An indication that the dosage form has yet to be assigned. Unassigned C96080 Stability Container Closure System Terminology C96122 Vacuum Sealed Composite Container Closure Metal/Plastic closures used on packages where the pressure inside the package is less than atmospheric. Vacuum, Composite Metal/Plastic closures used on packages where the pressure inside the package is less than atmospheric. C96080 Stability Container Closure System Terminology C96119 Vacuum Sealed Metal Container Closure Metal closures used on packages where the pressure inside the package is less than atmospheric. Vacuum, Metal Metal closures used on packages where the pressure inside the package is less than atmospheric. C96080 Stability Container Closure System Terminology C96121 Vacuum Sealed Plastic Container Closure Plastic closures used on packages where the pressure inside the package is less than atmospheric. Vacuum, Plastic Plastic closures used on packages where the pressure inside the package is less than atmospheric. C96080 Stability Container Closure System Terminology C96138 Valved Dispensing Plastic Container Closure Dispensing closure incorporating a product-flow controlling valve within the orifice. Product will not dispense from the package until sufficient squeezing pressure is applied to the flexible container to cause the valve to open. Valved (Dispensing), Plastic Dispensing closure incorporating a product-flow controlling valve within the orifice. Product will not dispense from the package until sufficient squeezing pressure is applied to the flexible container to cause the valve to open. C96081 Stability Container Type Terminology C43226 Parenteral Vial A container designed for use with parenteral drug products. Vial C96081 Stability Container Type Terminology C43208 Dispensing Vial A vial that is used by the pharmacist to dispense the prescribed medication. Vial, Dispensing C96081 Stability Container Type Terminology C43209 Glass Vial A glass container designed for use with parenteral drug products. Vial, Glass C96081 Stability Container Type Terminology C43210 Multi Dose Vial A vial intended to contain more than one dose of the drug product. Vial, Multi-Dose C96081 Stability Container Type Terminology C43211 Patent Delivery System Vial A vial that has a patented delivery system. Vial, Patent Delivery System C96081 Stability Container Type Terminology C43212 Pharmacy Bulk Vial A container of a sterile preparation whose contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion or, through a sterile transfer device, for the filling of empty sterile syringes. Vial, Pharmacy Bulk Package C96081 Stability Container Type Terminology C43213 Piggyback Vial A vial that contains a parenteral preparation that can be attached directly to the tubing of a parenterally administered fluid. Vial, Piggyback C96081 Stability Container Type Terminology C43214 Plastic Vial A plastic container designed for use with parenteral drug products. Vial, Plastic C96081 Stability Container Type Terminology C43215 Single Dose Vial A vial containing a single unit of a parenteral drug product. Vial, Single-Dose C96081 Stability Container Type Terminology C43216 Single Use Vial A vial where a single dose of a parenteral drug product can be removed, and then the vial and its remaining contents can be disposed. Vial, Single-Use C96074 Stability Product Form Terminology C43003 Wafer Dosage Form A solid composed of a thin slice of material that contain active and/or inert ingredient(s). Wafer C96082 Stability Study Storage Condition Terminology C96147 WHO Temperature/Humidity Storage Condition WHO WHO Technical Report Series, No.953, 2009. Stability testing of active pharmaceutical ingredients and finished pharmaceutical products.