C 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 C 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 C 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 C 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 C 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 C 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 C 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 C C96074 Stability Product Form Terminology C42679 Douche Dosage Form A substance intended for use as a vaginal irrigant. Douch C C96074 Stability Product Form Terminology C42763 Dressing Dosage Form A substance intended for administration in or on a wound. Dressing C C96074 Stability Product Form Terminology C42887 Aerosol Dosage Form Contents packaged under pressure that are released upon activation of an appropriate valve system. Aerosol C 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 C 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 C C96074 Stability Product Form Terminology C42890 Bead Dosage Form A solid in the shape of a small sphere. Bead C C96074 Stability Product Form Terminology C42891 Block Dosage Form A solid or semi-solid in the shape of a square or rectangle. Block C 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 C C96074 Stability Product Form Terminology C42893 Chewable Tablet Dosage Form A tablet designed to be chewed to release the active and/or inert ingredient(s). Tablet, Chewable C 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 C C96074 Stability Product Form Terminology C42895 Coated Capsule Dosage Form A capsule that contains an additional outer layer over the capsule shell. Capsule, Coated C 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 C C96074 Stability Product Form Terminology C42897 Coated Tablet Dosage Form A tablet whose outer shell is covered with a substance. Tablet, Coated C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C C96074 Stability Product Form Terminology C42914 Emulsion for Injection Dosage Form An emulsion intended for injection. Injection, Emulsion C C96074 Stability Product Form Terminology C42915 Enema Dosage Form A solution or suspension intended for administration into the rectum. Enema C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C C96074 Stability Product Form Terminology C42936 Gelatin Coated Capsule Dosage Form A capsule covered with a thin layer of gelatin. Capsule, Gelatin Coated C 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 C C96074 Stability Product Form Terminology C42938 Granule Dosage Form A solid composed of small particles or grains. Granule C C96074 Stability Product Form Terminology C42939 Granule for Solution Dosage Form A granule intended for administration as a solution. Granule, for Solution C C96074 Stability Product Form Terminology C42940 Granule for Suspension Dosage Form A granule intended for administration as a suspension. Granule, for Suspension C C96074 Stability Product Form Terminology C42941 Gum Dosage Form A semi-solid composed of a sticky, mucilaginous polysaccharide. Gum C C96074 Stability Product Form Terminology C42942 Implant Dosage Form A solid intended for insertion securely within the body. Implant C C96074 Stability Product Form Terminology C42943 Implantable Pellet Dosage Form A pellet intended for insertion securely within the body. Pellet, Implantable C C96074 Stability Product Form Terminology C42944 Inhalant Dosage Form Vaporized active and/or inert ingredient(s) intended for administration by inhalation. Inhalant C C96074 Stability Product Form Terminology C42945 Injectable Solution Dosage Form A solution intended for injection. Injection, Solution C C96074 Stability Product Form Terminology C42946 Injectable Dosage Form A substance intended for injection. Injection C C96074 Stability Product Form Terminology C42947 Irrigant Dosage Form A solution or suspension used to bathe or flush open wounds or body cavities. Irrigant C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C C96074 Stability Product Form Terminology C42979 Rinse Dosage Form A solution or suspension intended for irrigation purposes. Rinse C 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 C 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 C 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 C C96074 Stability Product Form Terminology C42983 Soap Dosage Form An anionic surfactant for cleansing. Soap C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C C96074 Stability Product Form Terminology C42992 Sugar Coated Tablet Dosage Form A tablet covered with sugar. Tablet, Sugar Coated C 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 C 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 C C96074 Stability Product Form Terminology C42995 Injectable Suspension Dosage Form A suspension intended for injection. Injection, Suspension C 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 C 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 C 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 C 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 C 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 C 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 C C96074 Stability Product Form Terminology C43002 Unassigned Dosage Form An indication that the dosage form has yet to be assigned. Unassigned C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C 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 C C96074 Stability Product Form Terminology C47892 Tampon Dosage Form A solid composed of a plug made from absorbent material. Tampon C 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 C 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 C 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 C 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 C 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 C 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 C C96074 Stability Product Form Terminology C47916 Kit Dosage Form A collection of unrelated materials that are used together to orchestrate dosage administration. Kit C 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 C C96074 Stability Product Form Terminology C48624 Dosage Form Not Applicable An indication that the dosage form is not relevant or appropriate. Not Applicable C C96074 Stability Product Form Terminology C60884 Cloth Dosage Form A solid composed active and/or inert ingredient(s) in a woven absorbent material. Cloth C 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 C 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 C 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 C C96074 Stability Product Form Terminology C60927 Dosage Form for Solution A substance intended for administration as a solution. For Solution C C96074 Stability Product Form Terminology C60928 Dosage Form for Suspension A substance intended for administration as a suspension. For Suspension C 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 C 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 C 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 C C96074 Stability Product Form Terminology C60933 Insert Dosage Form A solid or semi-solid intended for administration within the body. Insert C 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 C 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 C 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 C 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 C 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 C 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 C C96074 Stability Product Form Terminology C60992 Drop Solution Dosage Form A solution intended for administration in a drop-wise fashion. Solution/Drops C 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 C C96074 Stability Product Form Terminology C60995 Drop Suspension Dosage Form A suspension intended for administration in a drop-wise fashion. Suspension/Drops C 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 C 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 C 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 C 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 C 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 C 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 C C96074 Stability Product Form Terminology C87536 Smoke Stick Dosage Form A pharmaceutical dosage form comprised of a stick that is smoked. Smoke Stick C C96074 Stability Product Form Terminology C87537 Smoke Paper Dosage Form A pharmaceutical dosage form comprised of paper that is smoked. Smoke Paper C 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 C 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 C 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 C C96074 Stability Product Form Terminology C87541 Lyophilized Powder Dosage Form A pharmaceutical dosage form comprised of lyophilized powder. Powder, Lyophilized C C96074 Stability Product Form Terminology C87542 Pendant Dosage Form A pharmaceutical dosage form containing active substance(s) delivered via pendant. Pendant C C96078 Stability Study Interpretation Terminology C44281 Failed Having undergone failure; did not accomplish the intended purpose. Failed C C96078 Stability Study Interpretation Terminology C81275 Pass One of two possible results of a pass/fail assessment; when the result satisfies a condition. Passed C 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 C 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 C C96081 Stability Container Type Terminology C43165 Ampule A container capable of being hermetically sealed, intended to hold sterile materials. Ampule C C96081 Stability Container Type Terminology C43166 Applicator A pre-filled non-injectable pipette, syringe or tube. Applicator C C96081 Stability Container Type Terminology C43167 Bag A sac or pouch. Bag C 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 C C96081 Stability Container Type Terminology C43169 Bottle A vessel with a narrow neck designed to accept a specific closure. Bottle C 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 C 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 C C96081 Stability Container Type Terminology C43172 Glass Bottle A glass vessel with a narrow neck designed to accept a specific closure. Bottle, Glass C C96081 Stability Container Type Terminology C43173 Plastic Bottle A plastic vessel with a narrow neck designed to accept a specific closure. Bottle, Plastic C 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 C 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 C 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 C C96081 Stability Container Type Terminology C43177 Applicator Bottle A bottle which includes a device for applying its contents. Bottle, with Applicator C C96081 Stability Container Type Terminology C43178 Box A square or rectangular vessel, usually made of cardboard or plastic. Box C 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 C C96081 Stability Container Type Terminology C43180 Can A cylindrical vessel, usually made of metal. Can C C96081 Stability Container Type Terminology C43181 Canister A type of can for holding a drug product. Canister C C96081 Stability Container Type Terminology C43182 Carton A cardboard box or container which is usually considered a secondary packaging component. Carton C 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 C 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 C C96081 Stability Container Type Terminology C43185 Cello Pack A plastic 'clamshell' [thin plastic pre-formed structure for a device]. Cello Pack C C96081 Stability Container Type Terminology C43186 Container An object that can be used to hold things. Container C C96081 Stability Container Type Terminology C43187 Cup A bowl-shaped container. Cup C 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 C C96081 Stability Container Type Terminology C43189 Gas Cylinder A container designed specifically to hold gases. Cylinder C 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 C 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 C 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 C 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 C C96081 Stability Container Type Terminology C43194 Inhaler Refill A container of medication intended to refill an inhaler. Inhaler, Refill C 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 C 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 C 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 C 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 C 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 C 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 C 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 C C96081 Stability Container Type Terminology C43202 Syringe A device for the administration of parenteral 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 C 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 C 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 C 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 C 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 C 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 C C96081 Stability Container Type Terminology C43208 Dispensing Vial A vial that is used by the pharmacist to dispense the prescribed medication. Vial, Dispensing C C96081 Stability Container Type Terminology C43209 Glass Vial A glass container designed for use with parenteral drug products. Vial, Glass C 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 C C96081 Stability Container Type Terminology C43211 Patent Delivery System Vial A vial that has a patented delivery system. Vial, Patent Delivery System C 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 C 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 C C96081 Stability Container Type Terminology C43214 Plastic Vial A plastic container designed for use with parenteral drug products. Vial, Plastic C C96081 Stability Container Type Terminology C43215 Single Dose Vial A vial containing a single unit of a parenteral drug product. Vial, Single-Dose C 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 C C96081 Stability Container Type Terminology C43226 Parenteral Vial A container designed for use with parenteral drug products. Vial C 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 C C96081 Stability Container Type Terminology C48626 Package Type Not Stated The package type is not stated or is unavailable. Not Stated C 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 C 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 C 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 C 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 C 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