sign in sign up
<<
Home , Dosage form, Liniment, Paste (rheology)

Home Development & Approval Process (Drugs) Forms & Submission Requirements Electronic Submissions to CDER Data Standards Manual (monographs) Drugs

Dosage Form FDA Data Element Number. None. CDER Data Element Number. C-DRG-00201 Data Element Name. . Data Element OID: 2.16.840.1.113883.3.26.1.1.2 Data Element NCI Concept ID: C42636 Version Number. 008 Description. This standard provides for all dosage forms. The granularity of data often requires that more specific dosage form terms be stored in automated databases than are represented in publications. These dosage form terms are available not only for use in databases that track approved drug products, but also for drug products such as: those that have not been approved, investigational drug products, homeopathic drug products, biologic products, veterinary drug products, and bulk drug products. A ‘use restrictions’ column is being added to help identify where a particular dosage form set or subset should be used (a=CDER Databases, b=NDC Directory, c=Orange Book). The definitions for , , Ointment, and were revised on June 21, 2006 to include information that would assist the user in differentiating between these dosage forms. These changes were the result of discussions during an FDA Advisory Committee with an open public forum, scientific studies that were published in refereed pharmaceutical journals, and internal discussions by Agency personnel, including the usual adherence to the criteria that are specified in MaPP 7600.4. A 1999 and Drug Administration Draft Guidance for Industry states: "A dosage form is the way of identifying the drug in its physical form. In determining dosage form, FDA examines such factors as (1) physical appearance of the drug product, (2) physical form of the drug product prior to dispensing to the patient, (3) the way the product is administered, (4) frequency of dosing, and (5) how pharmacists and other health professionals might recognize and handle the product." Source. FDA Databases, the Orange Book, and the NDC Directory for terms. Relationship. FDA Specifications. None. CDER Specifications. Dosage Form shall consist of an alphabetic term which has a maximum length restricted to 240 characters, with the comma and hyphen being the only punctuation permissible. FDA codes representing these dosage forms shall consist of three digits. Structured Product Labeling and all new databases should use the NCI ConceptID rather than the FDA code. FDA Approved Date. None. CDER Approved Date. April 14, 1992. FDA Revised Date. CDER Revised Dates. January 12, 1993; October 11, 1994; January 10, 1995; December 12, 1996; November 8, 1996; April 21, 1997; November 14, 1997; February 24, 1998; November 2, 1998; December 21, 2000; June 6, 2002; April 12, 2005; January 11, 2006; April 20, 2006; May 13; 2006; June 21, 2006; September 27, 2006; December 15, 2006 Data Values. USE SHORT FDA NCI NAME DEFINITION RESTRICTIONS NAME CODE CONCEPT ID A product that is packaged under a,b,c AER 246 C42887 pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal ), mouth (lingual aerosols), or lungs ( aerosols). AEROSOL, FOAM A dosage form containing one or a,b,c AER FOAM 800 C42888 more active ingredients, surfactants, aqueous or nonaqueous , and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged. AEROSOL, A pressurized dosage form consisting a,b,c AER MET 339 C42960 METERED of metered valves which allow for the delivery of a uniform quantity of spray upon each activation. AEROSOL, A product that is packaged under a,b AER PWD 801 C42971 pressure and contains therapeutically active ingredients, in the form of a powder, that are released upon activation of an appropriate valve system. AEROSOL, SPRAY An aerosol product which utilizes a a,b AER SPRAY 247 C42889 compressed as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to of medicinal agents in aqueous . BAR, CHEWABLE A dosage form usually in the a,b,c BAR CHEW 347 C42892 form of a rectangle that is meant to be chewed. BEAD A solid dosage form in the shape of a a,b BEAD 317 C42890 small ball. BEAD, IMPLANT, A small sterile solid mass consisting a BEAD IMP ER 802 C43451 EXTENDED of a highly purified drug intended for RELEASE implantation in the body which would allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form. BLOCK Solid dosage form, usually in the a,b BLOCK 803 C42891 shape of a square or rectangle. A solid oral dosage form consisting of a,b,c CAP 600 C25158 a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. 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 ingredients that can be poured or squeezed. CAPSULE, A solid dosage form in which the druga,b CAP COATED602 C42895 COATED is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated coating. CAPSULE, A solid dosage form in which the druga,b,c CAP COATED603 C42896 COATED PELLETS is enclosed within either a hard or PELLETS soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which varying amounts of coating have been applied. CAPSULE, A solid dosage form in which the druga,b CAP COATED611 C42917 COATED, is enclosed within either a hard or ER EXTENDED soft soluble container or "shell" made RELEASE from a suitable form of gelatin; additionally, the capsule is covered in a designated coating, and which releases a drug (or drugs) in such a manner to allow at least a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. CAPSULE, A solid dosage form in which the druga,b,c CAP DR 620 C42902 DELAYED RELEASEis enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms. CAPSULE, A solid dosage form in which the druga,b,c CAP DR 621 C42904 DELAYED RELEASEis enclosed within either a hard or PELLETS PELLETS soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines. CAPSULE, A solid dosage form in which the druga,b,c CAP ER 610 C42916 EXTENDED is enclosed within either a hard or RELEASE soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. CAPSULE, FILM A solid dosage form in which the druga CAP FILM 612 C42928 COATED, is enclosed within either a hard or COATED ER EXTENDED soft soluble container or "shell" made RELEASE from a suitable form of gelatin; additionally, the capsule is covered in a designated film coating, and which releases a drug (or drugs) in such a manner to allow at least a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. CAPSULE, A solid dosage form in which the druga,b CAP GELATIN605 C42936 GELATIN COATED is enclosed within either a hard or COATED soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal. CAPSULE, LIQUID A solid dosage form in which the druga,b CAP LIQ 606 C42954 FILLED is enclosed within a soluble, gelatin FILLED shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle. CEMENT A substance that serves to produce a CEMENT 252 C45414 solid union between two surfaces. CIGARETTE A narrow tube of cut tobacco (or a,b CIGARETTE 253 C42678 other similar material) enclosed in paper and designed for . CLOTH A large piece of relatively flat, a,b,c CLOTH 845 C60884 absorbent material that contains a drug. It is typically used for applying or for cleansing. CONCENTRATE A liquid preparation of increased a,b,c CONC 280 C60891 strength and reduced volume which is usually diluted prior to administration. CONE A solid dosage form bounded by a a,b CONE 049 C42900 circular base and the surface formed by line segments joining every point of the boundary of the base to a common vertex. A cone (usually containing antibiotics) is normally placed below the gingiva after a dental extraction. CORE, EXTENDED An ocular system placed in the eye a,b CORE ER 804 C42919 RELEASE from which the drug diffuses through a membrane at a constant rate over a specified period. CREAM An , semisolid3 dosage form, a,b,c CREAM 805 C28944 usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. CREAM, A cream dosage form that enhances a,b,c CREAM AUG 365 C60897 AUGMENTED . Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered "augmented”. CRYSTAL A naturally produced angular solid of a CRYSTAL 051 C42901 definite form in which the ultimate units from which it is built up are systematically arranged; they are usually evenly spaced on a regular space lattice. CULTURE The propagation of microorganisms ora CULTURE 281 C45415 of living tissue sells in special media conducive to their growth. DIAPHRAGM A device usually dome-shaped, worn a DIAPHRAGM 255 C47890 during copulation over the cervical mouth for prevention of conception or infection. DISC A circular plate-like organ or a,b,c DISC 256 C43525 structure. A liquid preparation, intended for the a DOUCHE 838 C42679 irrigative cleansing of the , that is prepared from , liquid solutions, or liquid concentrates and contains one or more chemical substances dissolved in a suitable or mutually miscible solvents. DRESSING The application of various materials a,b,c DRESSING 285 C42763 for protecting a wound. DRUG DELIVERY Modern technology, distributed with a DDS 259 C17423 SYSTEM or as a part of a drug product that allows for the uniform release or targeting of drugs to the body. A clear, pleasantly flavored, a,b,c ELIXIR 807 C42912 sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use. EMULSION A dosage form consisting of a two- a,b,c EMULSION 052 C42913 phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.) A rectal preparation for therapeutic, a,b,c ENEMA 286 C42915 diagnostic, or nutritive purposes. EXTRACT A concentrated preparation of a,b EXTRACT 287 C42929 vegetable or animal drugs obtained by removal of the active constituents of the respective drugs with a suitable menstrua, evaporation of all or nearly all of the solvent, and adjustment of the residual masses or powders to the prescribed standards. FIBER, EXTENDED A slender and elongated solid thread- a,b,c FIBER ER 847 C60926 RELEASE like substance that delivers drug in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. FILM A thin layer or coating. a,b FILM 061 C42932 FILM, EXTENDED A drug delivery system in the form of a,b,c FILM ER 810 C42920 RELEASE a film that releases the drug over an extended period in such a way as to maintain constant drug levels in the blood or target tissue. FILM, SOLUBLE A thin layer or coating which is a,b FILM 063 C42984 susceptible to being dissolved when SOLUBLE in contact with a liquid. FOR A product, usually a solid, intended a,c FOR SOL 848 C60927 for solution prior to administration. FOR A product, usually a solid, intended a,c FOR SUSP 849 C60928 for suspension prior to administration. FOR SUSPENSION,A product, usually a solid, intended a,c FOR SUSP ER850 C60929 EXTENDED for suspension prior to administration; RELEASE once the suspension is administered, the drug will be released at a constant rate over a specified period. GAS Any elastic aeriform in which the a,b,c GAS 064 C42933 molecules are separated from one another and so have free paths. A semisolid3 dosage form that a,b,c GEL 066 C42934 contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles. GEL, DENTIFRICE A combination of a dentifrice a,b GEL DENT 806 C42906 (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth. GEL, METERED A gel preparation, with metered dose a,b,c GEL MET 851 C60930 valves, which allow for the delivery of a uniform quantity of gel upon each activation. GENERATOR An apparatus for the formation of a,b GENERATOR 289 C48193 vapor or gas from a liquid or solid by heat or chemical action. The term GENERATOR also applies to radioactive columns from which radionuclides are provided.

GLOBULE Also called pellets or pilules, are a,b GLOBULE 808 C42937 made of pure sucrose, lactose, or other polysaccharides. They are formed into small globular masses of various sizes, and are medicated by placing them in a and adding the liquid drug attenuation in the proportion not less than one percent (v/w). After shaking, the medicated globules are dried at temperatures not to exceed 40 degrees Centigrade. GRAFT A slip of skin or of other tissue for a,b GRAFT 290 C45416 implantation. GRANULE A small particle or grain. a,b,c GRAN 078 C42938 GRANULE, A small medicinal particle or grain to a,c GRAN DR 820 C42903 DELAYED RELEASEwhich an enteric or other coating has been applied, thus delaying release of the drug until its passage into the intestines. GRANULE, A small particle or grain containing a a,b,c GRAN EFFRV 080 C42909 EFFERVESCENT medicinal agent in a dry mixture usually composed of sodium bicarbonate, citric acid, and tartaric acid which, when in contact with water, has the capability to release gas, resulting in effervescence. GRANULE, FOR A small medicinal particle or grain a,b GRAN F/SOL 809 C42939 SOLUTION made available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient. GRANULE, FOR A small medicinal particle or grain a,b GRAN 819 C42940 SUSPENSION made available in its more stable dry F/SUSP form, to be reconstituted with solvent just before dispensing to form a suspension; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient. GRANULE, FOR A small medicinal particle or grain a GRAN 811 C42921 SUSPENSION, made available in its more stable dry F/SUSP ER EXTENDED form, to be reconstituted with RELEASE solvent just before dispensing to form a suspension; the extended release system achieves slow release of the drug over an extended period of time and maintains constant drug levels in the blood or target tissue. GUM A mucilaginous excretion from various a,b GUM 084 C42941 plants. GUM, CHEWING A sweetened and flavored insoluble a,b,c GUM 085 C42894 plastic material of various shapes CHEWING which when chewed, releases a drug substance into the oral cavity. GUM, RESIN Natural mixture of gum and resin, a,b GUM RESIN 087 C42978 usually obtained as exudations from plants. IMPLANT A material containing drug intended a,b,c IMP 715 C42942 to be inserted securely of deeply in a living site for growth, slow release, or formation of an organic union. INHALANT A special class of a,b,c INHALANT 293 C42944 consisting of a drug or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an . INJECTABLE, An , which either consists of a,c INJ LIPOS 852 C60931 LIPOSOMAL or forms (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance). INJECTION A sterile preparation intended for a,b INJ 700 C42946 parenteral use; five distinct classes of injections exist as defined by the USP. INJECTION, An emulsion consisting of a sterile, a,b INJ 701 C42914 EMULSION pyrogen-free preparation intended to EMULSION be administered parenterally. INJECTION, LIPID [definition pending] a INJ LIPID 716 C42950 COMPLEX COMPLEX INJECTION, A sterile preparation intended for a,b INJ PWD 702 C42974 POWDER, FOR reconstitution to form a solution for F/SOL SOLUTION parenteral use. INJECTION, A sterile preparation intended for a,b INJ PWD 703 C42976 POWDER, FOR reconstitution to form a suspension F/SUSP SUSPENSION for parenteral use. INJECTION, A dried preparation intended for a,b INJ PWD 710 C42977 POWDER, FOR reconstitution to form a suspension F/SUSP ER SUSPENSION, for parenteral use which has been EXTENDED formulated in a manner to allow at RELEASE least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution). INJECTION, A sterile freeze dried preparation a,b INJ PWD LYO713 C42959 POWDER, intended for reconstitution for F/LS LYOPHILIZED, FORparenteral use which has been LIPOSOMAL formulated in a manner that would SUSPENSION allow liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance, either within a lipid bilayer or in an aqueous space) to be formed upon reconstitution. INJECTION, A dosage form intended for the a,b INJ PWD LYO705 C42957 POWDER, solution prepared by lyophilization F/SOL LYOPHILIZED, FOR("freeze drying"), a process which SOLUTION involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections. INJECTION, A liquid preparation, intended for a,b INJ PWD LYO706 C42958 POWDER, parenteral use that contains F/SUSP LYOPHILIZED, FORsuspended in a suitable fluid medium SUSPENSION and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension are prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures. INJECTION, A sterile freeze dried preparation a,b INJ PWD LYO712 C42956 POWDER, intended for reconstitution for F/SUSPER LYOPHILIZED, FORparenteral use which has been SUSPENSION, formulated in a manner to allow at EXTENDED least a reduction in dosing frequency RELEASE as compared to that drug presented as a conventional dosage form (e.g., as a solution). INJECTION, A liquid preparation containing one or a,b INJ SOL 708 C42945 SOLUTION more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection. INJECTION, A sterile preparation for parenteral a,b INJ SOL 709 C42899 SOLUTION, use which, upon the addition of CONC CONCENTRATE suitable solvents, yields a solution conforming in all respects to the requirements for Injections. INJECTION, A liquid preparation, suitable for a,b INJ SUSP 704 C42995 SUSPENSION injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa. INJECTION, A sterile preparation intended for a,b INJ SUSP ER 711 C42926 SUSPENSION, parenteral use which has been EXTENDED formulated in a manner to allow at RELEASE least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug- releasing, conventional solid dosage form). INJECTION, A liquid preparation, suitable for a,b INJ SUSP 714 C42951 SUSPENSION, injection, which consists of an oil LIPOS LIPOSOMAL phase dispersed throughout an aqueous phase in such a manner that liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance, either within a lipid bilayer or in an aqueous space) are formed. INJECTION, A liquid preparation, suitable for a INJ SUSP 840 C42988 SUSPENSION, injection, which consists of solid SON SONICATED particles dispersed throughout a liquid phase in which the particles are not soluble. In addition, the product is sonicated while a gas is bubbled through the suspension, and this results in the formation of microspheres by the solid particles. INSERT A specially formulated and shaped a,c INSERT 853 C60933 non-encapsulated solid preparation intended to be placed into a non- rectal orifice of the body, where drug is released, generally for localized effects. INSERT, A specially formulated and shaped a,b,c INSERT ER 812 C42922 EXTENDED non-encapsulated solid preparation RELEASE intended to be placed into a non- rectal orifice of the body, where the medication is released, generally for localized effects; the extended release preparation is designed to allow for a reduction in dosing frequency. INTRAUTERINE A device inserted and left in the a,b,c IUD 260 C47915 DEVICE uterus to prevent effective conception. IRRIGANT A sterile solution intended to bathe a,b IRRIGANT 830 C42947 or flush open wounds or body cavities; they're used topically, never parenterally. JELLY A class of , which are semisolid a,b,c JELLY 072 C42948 systems that consist of suspensions made up of either small inorganic particles or large organic molecules interpenetrated by a liquid--in which the structural coherent matrix contains a high portion of liquid, usually water. KIT A packaged collection of related a,b KIT 261 C47916 material. LINER, DENTAL A material applied to the inside of thea,b LINER 316 C45413 dental cavity, for protection or DENTAL insulation of the surface. A solution or mixture of various a,b LINIMENT 298 C42949 substances in oil, alcoholic solutions of soap, or intended for external application. LIPSTICK A waxy solid, usually colored a,b LIPSTICK 265 C42952 cosmetic, in stick form for the lips. LIQUID A dosage form consisting of a pure a,b,c LIQ 299 C42953 chemical in its liquid1 state. This dosage form term should not be applied to solutions. LIQUID, A liquid that delivers a drug in such a a,b,c LIQ ER 854 C60934 EXTENDED manner to allow a reduction in dosing RELEASE frequency as compared to that drug (or drugs) presented as a conventional dosage form. LOTION An emulsion, liquid1 dosage form. a,b,c LOTION 300 C29167 This dosage form is generally for external application to the skin.2 LOTION, A lotion dosage form that enhances a,b,c LOTION AUG 364 C60957 AUGMENTED drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered "augmented". LOTION/SHAMPOOA lotion dosage form which has a a,b,c LOTION 855 C60958 soap or detergent that is usually used to clean the hair and scalp; it is often used as a vehicle for dermatologic agents. LOZENGE A solid preparation containing one or a,b LOZENGE 831 C42955 more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A is a lozenge on a stick. An aqueous solution which is most a,b MOUTHWASH832 C29269 often used for its , refreshing, or antiseptic effect. NOT APPLICABLE The use of a dosage form term is not a,b,c NOT 313 C48624 relevant or appropriate. APPLICABLE OIL An unctuous, combustible substance a,b,c OIL 098 C42965 which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils. OINTMENT A semisolid3 dosage form, usually a,b,c OINTMENT 101 C42966 containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. OINTMENT, An ointment dosage form that a,b,c OINTMENT 366 C60984 AUGMENTED enhances drug delivery. AUG Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered "augmented". PACKING A material, usually covered by or a,b PACKING 839 C47887 impregnated with a drug that is inserted into a body cavity or between the tooth enamel and the gingival margin. PASTE A semisolid3 dosage form, containing a,b,c PASTE 103 C42967 a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes. PASTE, A paste formulation intended to cleana,b PASTE DENT 104 C42907 DENTIFRICE and/or polish the teeth, and which may contain certain additional agents. An aromatic preparation, often with aa,c PASTILLE 341 C60985 pleasing flavor, usually intended to dissolve in the mouth. PATCH A drug delivery system that often a,b,c PATCH 843 C42968 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. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’. PATCH, A drug delivery system in the form of a,b PATCH ER 813 C42923 EXTENDED a patch that releases the drug in RELEASE such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form). PATCH, A drug delivery system in the form of a,b PATCH ER 814 C42911 EXTENDED a patch which is controlled by an ELCON RELEASE, electric current that releases the ELECTRICALLY drug in such a manner that a CONTROLLED reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form). PELLET A small sterile solid mass consisting a,b,c PELLET 105 C42969 of a highly purified drug (with or without ) made by the formation of granules, or by compression and molding. PELLET, A small sterile solid mass consisting a PELLET IMP 844 C42943 IMPLANTABLE of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding; they are intended for implantation in the body (usually subcutaneously) for the purpose of providing continuous release of the drug over long periods of time. PELLETS, A solid dosage form in which the druga PELLETS 842 C42918 COATED, itself is in the form of granules to COATED ER EXTENDED which varying amounts of coating RELEASE have been applied, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. PILL A small, round solid dosage form a,b PILL 107 C25394 containing a medicinal agent intended for . PLASTER Substance intended for external a,b PLASTER 108 C42970 application made of such materials and of such consistency as to adhere to the skin and attach to a dressing; plasters are intended to afford protection and support and/or to furnish an occlusion and macerating action and to bring medication into close contact with the skin. POULTICE A soft, moist mass of meal, herbs, a,b POULTICE 109 C47913 seed, etc., usually applied hot in cloth that consists of gruel-like consistency. POWDER An intimate mixture of dry, finely a,b,c PWD 110 C42972 divided drugs and/or chemicals that may be intended for internal or external use. POWDER, A powder formulation intended to a,b PWD DENT 115 C42908 DENTIFRICE clean and/or polish the teeth, and which may contain certain additional agents. POWDER, FOR An intimate mixture of dry, finely a,b PWD F/SOL 833 C42973 SOLUTION divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution. POWDER, FOR An intimate mixture of dry, finely a,b PWD F/SUSP 834 C42975 SUSPENSION divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle). POWDER, An powder dosage form that is a,c PWD MET 841 C42961 METERED situated inside a container that has a mechanism to deliver a specified quantity. RING A small circular object with a vacant a,b,c RING 856 C60988 circular center that is usually intended to be placed in the body by special inserters, where the medication is released, generally for localized effects. RINSE A liquid used to cleanse by flushing. a,b RINSE 303 C42979 SALVE A thick ointment or cerate (a fat or a,b SALVE 137 C42980 wax based preparation with a consistency between an ointment and a plaster). SHAMPOO A liquid soap or detergent used to a,b,c SHAMPOO 304 C42981 clean the hair and scalp and is often used as a vehicle for dermatologic agents. SHAMPOO, A liquid soap or detergent containing a,b SHAMPOO 193 C42982 SUSPENSION one or more solid, insoluble SUSP substances dispersed in a liquid vehicle that is used to clean the hair and scalp and is often used as a vehicle for dermatologic agents. SOAP Any compound of one or more fatty a,b,c SOAP 305 C42983 acids, or their equivalents, with an alkali; soap is detergent and is much employed in , , and in making pills. It is also a mild aperient, antacid and antiseptic. SOLUTION A clear, homogeneous liquid1 dosage a,b,c SOL 138 C42986 form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents. SOLUTION, A liquid preparation (i.e., a substancea,b SOL CONC 835 C42898 CONCENTRATE that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its nonactive parts. SOLUTION, FOR A solution for the preparation of an a,c SOL F/SLUSH321 C42987 SLUSH iced saline slush, which is administered by irrigation and used to induce regional hypothermia (in conditions such as certain open heart and kidney surgical procedures) by its direct application.

SOLUTION, GEL A solution, which after usually being a,c SOL GF 858 C60994 FORMING / DROPS administered in a drop-wise fashion, DROPS forms a gel. SOLUTION, GEL A solution that forms a gel when it a SOL GF ER 717 C42935 FORMING, comes in contact with ocular fluid, EXTENDED and which allows at least a reduction RELEASE in dosing frequency. SOLUTION/ A solution which is usually a,b,c SOL DROPS 857 C60992 DROPS administered in a drop-wise fashion. SPONGE A porous, interlacing, absorbent a,b,c SPONGE 271 C47912 material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape. SPRAY A liquid minutely divided as by a jet a,b,c SPRAY 272 C42989 of air or steam. SPRAY, METERED A non-pressurized dosage form a,b,c SPRAY MET 345 C42962 consisting of valves which allow the dispensing of a specified quantity of spray upon each activation. SPRAY, A liquid preparation containing solid a,b SPRAY SUSP 195 C42990 SUSPENSION particles dispersed in a liquid vehicle and in the form of coarse droplets or as finely divided solids to be applied locally, most usually to the nasal- pharyngeal tract, or topically to the skin. STICK A dosage form prepared in a a,b STICK 273 C42991 relatively long and slender often cylindrical form. STRIP A long narrow piece of material. a,b STRIP 274 C47914 A solid body of various weights and a,b,c SUPP 173 C42993 shapes, adapted for introduction into the rectal orifice of the ; they usually melt, soften, or dissolve at body temperature. SUPPOSITORY, A drug delivery system in the form of a,b,c SUPP ER 815 C42924 EXTENDED a suppository that allows for a RELEASE reduction in dosing frequency. SUSPENSION A liquid1 dosage form that contains a,b SUSP 177 C42994 solid particles dispersed in a liquid vehicle. SUSPENSION, A liquid preparation consisting of solida,b SUSP ER 816 C42925 EXTENDED particles dispersed throughout a RELEASE liquid phase in which the particles are not soluble; the suspension has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug- releasing, conventional solid dosage form). SUSPENSION/ A suspension which is usually a,c SUSP DROPS 859 C60995 DROPS administered in a dropwise fashion. SUTURE A strand or fiber used to hold wound a SUTURE 275 C47889 edges in apposition during healing. SWAB A small piece of relatively flat a,b,c SWAB 276 C47898 absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing. An oral solution containing high a,b,c SYRUP 307 C42996 concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions. A solid dosage form containing a,b,c TAB 500 C42998 medicinal substances with or without suitable diluents. TABLET, A solid dosage form containing a,b,c TAB CHEW 501 C42893 CHEWABLE medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after- taste. TABLET, COATED A solid dosage form that contains a,b TAB COATED502 C42897 medicinal substances with or without suitable diluents and is covered with a designated coating. TABLET, A solid dosage form containing a a,c TAB COATED860 C60997 COATED conglomerate of medicinal particles PART PARTICLES that have each been covered with a coating. TABLET, DELAYEDA solid dosage form which releases a a,b,c TAB DR 520 C42905 RELEASE drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms. TABLET, DELAYEDA solid dosage form containing a a,b TAB DR 521 C42997 RELEASE conglomerate of medicinal particles PARTICLES PARTICLES that have been covered with a coating which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms. TABLET, A tablet that, prior to administration, a,c TAB DISP 491 [Note: The DISPERSIBLE is intended to be placed in liquid, concept has where its contents will be distributed been entered evenly throughout that liquid. Note: as a synonym The term ‘tablet, dispersible’ is no for the longer used for approved drug dosage form products, and it has been replaced term TABLET, by the term ‘tablet, for suspension’. FOR SUSPENSION.] TABLET, A solid dosage form containing a,b,c TAB EFFRV 503 C42910 EFFERVESCENT mixtures of acids (e.g., citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water; it is intended to be dissolved or dispersed in water before administration. TABLET, A solid dosage form containing a druga,b,c TAB ER 510 C42927 EXTENDED which allows at least a reduction in RELEASE dosing frequency as compared to that drug presented in conventional dosage form. TABLET, FILM A solid dosage form that contains a,b TAB FILM 504 C42931 COATED medicinal substances with or without COATED suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer. TABLET, FILM A solid dosage form that contains a,b TAB FILM 511 C42930 COATED, medicinal substances with or without COATED ER EXTENDED suitable diluents and is coated with a RELEASE thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following . TABLET, FOR A tablet that forms a solution when a,c TAB FOR SOL523 C61004 SOLUTION placed in a liquid. TABLET, FOR A tablet that forms a suspension a,c TAB FOR 524 C61005 SUSPENSION when placed in a liquid (formerly SUSP referred to as a ‘dispersible tablet’). TABLET, A solid dosage form containing a,b TAB 505 C42964 MULTILAYER medicinal substances that have been MULTILAYER compressed to form a multiple- layered tablet or a tablet-within-a- tablet, the inner tablet being the core and the outer portion being the shell. TABLET, A solid dosage form containing a,b TAB 512 C42963 MULTILAYER, medicinal substances that have been MULTILAYER EXTENDED compressed to form a multiple- ER RELEASE layered tablet or a tablet-within-a- tablet, the inner tablet being the core and the outer portion being the shell, which, additionally, is covered in a designated coating; the tablet is formulated in such manner as to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form. TABLET, ORALLY A solid dosage form containing a,b,c TAB ORALLY 522 C42999 DISINTEGRATING medicinal substances which DIS disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue. TABLET, ORALLY A solid dosage form containing a,c TAB ORALLY 526 C61006 DISINTEGRATING, medicinal substances which DIS DR DELAYED RELEASEdisintegrates rapidly, usually within a matter of seconds, when placed upon the tongue, but which releases a drug (or drugs) at a time other than promptly after administration. TABLET, SOLUBLE A solid dosage form that contains a,b TAB 507 C42985 medicinal substances with or without SOLUBLE suitable diluents and possesses the ability to dissolve in . TABLET, SUGAR A solid dosage form that contains a,b TAB SUGAR 508 C42992 COATED medicinal substances with or without COATED suitable diluents and is coated with a colored or an uncolored water-soluble sugar. TAMPON A plug made of cotton, sponge, or a,b,c TAMPON 277 C47892 oakum variously used in surgery to plug the nose, vagina, etc., for the control of hemorrhage or the of secretions. TAPE A narrow woven fabric, or a narrow a,b,c TAPE 278 C47897 extruded synthetic (such as plastic), usually with an adhesive on one or both sides. An alcoholic or hydroalcoholic a,b TINCTURE 837 C43000 solution prepared from vegetable materials or from chemical substances. TROCHE A discoid-shaped solid containing the a,b TROCHE 363 C43001 medicinal agent in a suitably flavored base; troches are placed in the mouth where they slowly dissolve, liberating the active ingredients. UNASSIGNED A dosage form has yet to be a,b UNASSIGNED900 C43002 assigned. WAFER A thin slice of material containing a a,b WAFER 245 C43003 medicinal agent. Footnotes: 1 A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. 2 Previously the definition of a lotion was “The term lotion has been used to categorize many topical suspensions, solutions, and emulsions intended for application to the skin.” The current definition of a lotion is restricted to an emulsion. 3 A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear and generally exhibits plastic flow behavior. 4 A colloidal dispersion is a system in which particles of colloidal dimension (i.e., typically between 1 nm and 1 µm) are distributed uniformly throughout a liquid. 5 Percent water and volatiles are measured by a loss on drying test in which the sample is heated at 105°C until constant weight is achieved.

Page Last Updated: 04/30/2009 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Transparency Website Policies

U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA

For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive

Links on this page: