DRG00201

Data Element OID: 2.16.840.1.113883.3.26.1.1.2
Data Element NCI Concept ID: C42636

Description. This standard provides for all drug 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 Lotion, Cream, Ointment, and Paste 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A 1999 Food and Drug Administration Draft Guidance for Industry states: "A dosage form is the way of identifying the drug in its physical form.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."

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.

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

NAME	DEFINITION	USE RESTRICTIONS	SHORT NAME	FDA CODE	NCI CONCEPT ID
AEROSOL	A product that is packaged under 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 aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols).	a,b,c	AER	246	C42887
AEROSOL, FOAM	A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, 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.	a,b,c	AER FOAM	800	C42888
AEROSOL, METERED	A pressurized dosage form consisting of metered dose valves which allow for the delivery of a uniform quantity of spray upon each activation.	a,b,c	AER MET	339	C42960
AEROSOL, POWDER	A product that is packaged under pressure and contains therapeutically active ingredients, in the form of a powder, that are released upon activation of an appropriate valve system.	a,b	AER PWD	801	C42971
AEROSOL, SPRAY	An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.	a,b	AER SPRAY	247	C42889
BAR, CHEWABLE	A solid dosage form usually in the form of a rectangle that is meant to be chewed.	a,b,c	BAR CHEW	347	C42892
BEAD	A solid dosage form in the shape of a small ball.	a,b	BEAD	317	C42890
BEAD, IMPLANT, EXTENDED RELEASE	A small sterile solid mass consisting of a highly purified drug intended for 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.	a	BEAD IMP ER	802	C43451
BLOCK	Solid dosage form, usually in the shape of a square or rectangle.	a,b	BLOCK	803	C42891
CAPSULE	A solid oral dosage form consisting of 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 liquid ingredients that can be poured or squeezed.	a,b,c	CAP	600	C25158
CAPSULE, COATED	A solid dosage form in which the drug 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.	a,b	CAP COATED	602	C42895
CAPSULE, COATED PELLETS	A solid dosage form in which the drug is enclosed within either a hard or 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.	a,b,c	CAP COATED PELLETS	603	C42896
CAPSULE, COATED, EXTENDED RELEASE	A solid dosage form in which the drug 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, 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.	a,b	CAP COATED ER	611	C42917
CAPSULE, DELAYED RELEASE	A solid dosage form in which the drug is 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.	a,b,c	CAP DR	620	C42902
CAPSULE, DELAYED RELEASE PELLETS	A solid dosage form in which the drug is enclosed within either a hard or 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.	a,b,c	CAP DR PELLETS	621	C42904
CAPSULE, EXTENDED RELEASE	A solid dosage form in which the drug is enclosed within either a hard or 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.	a,b,c	CAP ER	610	C42916
CAPSULE, FILM COATED, EXTENDED RELEASE	A solid dosage form in which the drug 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 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.	a	CAP FILM COATED ER	612	C42928
CAPSULE, GELATIN COATED	A solid dosage form in which the drug is enclosed within either a hard or 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.	a,b	CAP GELATIN COATED	605	C42936
CAPSULE, LIQUID FILLED	A solid dosage form in which the drug is enclosed within a soluble, gelatin 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.	a,b	CAP LIQ FILLED	606	C42954
CEMENT	A substance that serves to produce solid union between two surfaces.	a	CEMENT	252	C45414
CIGARETTE	A narrow tube of cut tobacco (or other similar material) enclosed in paper and designed for smoking.	a,b	CIGARETTE	253	C42678
CLOTH	A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.	a,b,c	CLOTH	845	C60884
CONCENTRATE	A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration.	a,b,c	CONC	280	C60891
CONE	A solid dosage form bounded by a 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.	a,b	CONE	049	C42900
CORE, EXTENDED RELEASE	An ocular system placed in the eye from which the drug diffuses through a membrane at a constant rate over a specified period.	a,b	CORE ER	804	C42919
CREAM	An emulsion, semisolid³ dosage form, 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.	a,b,c	CREAM	805	C28944
CREAM, AUGMENTED	A cream dosage form that enhances 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”.	a,b,c	CREAM AUG	365	C60897
CRYSTAL	A naturally produced angular solid of 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.	a	CRYSTAL	051	C42901
CULTURE	The propagation of microorganisms or of living tissue sells in special media conducive to their growth.	a	CULTURE	281	C45415
DIAPHRAGM	A device usually dome-shaped, worn during copulation over the cervical mouth for prevention of conception or infection.	a	DIAPHRAGM	255	C47890
DISC	A circular plate-like organ or structure.	a,b,c	DISC	256	C43525
DOUCHE	A liquid preparation, intended for the irrigative cleansing of the vagina, that is prepared from powders, liquid solutions, or liquid concentrates and contains one or more chemical substances dissolved in a suitable solvent or mutually miscible solvents.	a	DOUCHE	838	C42679
DRESSING	The application of various materials for protecting a wound.	a,b,c	DRESSING	285	C42763
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.	a	DDS	259	C17423
ELIXIR	A clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use.	a,b,c	ELIXIR	807	C42912
EMULSION	A dosage form consisting of a two-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,b,c	EMULSION	052	C42913
ENEMA	A rectal preparation for therapeutic, diagnostic, or nutritive purposes.	a,b,c	ENEMA	286	C42915
EXTRACT	A concentrated preparation of 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.	a,b	EXTRACT	287	C42929
FIBER, EXTENDED RELEASE	A slender and elongated solid thread-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.	a,b,c	FIBER ER	847	C60926
FILM	A thin layer or coating.	a,b	FILM	061	C42932
FILM, EXTENDED RELEASE	A drug delivery system in the form of 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.	a,b,c	FILM ER	810	C42920
FILM, SOLUBLE	A thin layer or coating which is susceptible to being dissolved when in contact with a liquid.	a,b	FILM SOLUBLE	063	C42984
FOR SOLUTION	A product, usually a solid, intended for solution prior to administration.	a,c	FOR SOL	848	C60927
FOR SUSPENSION	A product, usually a solid, intended for suspension prior to administration.	a,c	FOR SUSP	849	C60928
FOR SUSPENSION, EXTENDED RELEASE	A product, usually a solid, intended for suspension prior to administration; once the suspension is administered, the drug will be released at a constant rate over a specified period.	a,c	FOR SUSP ER	850	C60929
GAS	Any elastic aeriform fluid in which the molecules are separated from one another and so have free paths.	a,b,c	GAS	064	C42933
GEL	A semisolid³ dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.⁴ A gel may contain suspended particles.	a,b,c	GEL	066	C42934
GEL, DENTIFRICE	A combination of a dentifrice (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.	a,b	GEL DENT	806	C42906
GEL, METERED	A gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity of gel upon each activation.	a,b,c	GEL MET	851	C60930
GENERATOR	An apparatus for the formation of 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.	a,b	GENERATOR	289	C48193
GLOBULE	Also called pellets or pilules, are 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 vial 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.	a,b	GLOBULE	808	C42937
GRAFT	A slip of skin or of other tissue for implantation.	a,b	GRAFT	290	C45416
GRANULE	A small particle or grain.	a,b,c	GRAN	078	C42938
GRANULE, DELAYED RELEASE	A small medicinal particle or grain to which an enteric or other coating has been applied, thus delaying release of the drug until its passage into the intestines.	a,c	GRAN DR	820	C42903
GRANULE, EFFERVESCENT	A small particle or grain containing a 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.	a,b,c	GRAN EFFRV	080	C42909
GRANULE, FOR SOLUTION	A small medicinal particle or grain 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.	a,b	GRAN F/SOL	809	C42939
GRANULE, FOR SUSPENSION	A small medicinal particle or grain made available in its more stable dry 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.	a,b	GRAN F/SUSP	819	C42940
GRANULE, FOR SUSPENSION, EXTENDED RELEASE	A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with 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.	a	GRAN F/SUSP ER	811	C42921
GUM	A mucilaginous excretion from various plants.	a,b	GUM	084	C42941
GUM, CHEWING	A sweetened and flavored insoluble plastic material of various shapes which when chewed, releases a drug substance into the oral cavity.	a,b,c	GUM CHEWING	085	C42894
GUM, RESIN	Natural mixture of gum and resin, usually obtained as exudations from plants.	a,b	GUM RESIN	087	C42978
IMPLANT	A material containing drug intended to be inserted securely of deeply in a living site for growth, slow release, or formation of an organic union.	a,b,c	IMP	715	C42942
INHALANT	A special class of inhalations 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 inhaler.	a,b,c	INHALANT	293	C42944
INJECTABLE, LIPOSOMAL	An injection, which either consists of or forms liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance).	a,c	INJ LIPOS	852	C60931
INJECTION	A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.	a,b	INJ	700	C42946
INJECTION, EMULSION	An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally.	a,b	INJ EMULSION	701	C42914
INJECTION, LIPID COMPLEX	[definition pending]	a	INJ LIPID COMPLEX	716	C42950
INJECTION, POWDER, FOR SOLUTION	A sterile preparation intended for reconstitution to form a solution for parenteral use.	a,b	INJ PWD F/SOL	702	C42974
INJECTION, POWDER, FOR SUSPENSION	A sterile preparation intended for reconstitution to form a suspension for parenteral use.	a,b	INJ PWD F/SUSP	703	C42976
INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE	A dried preparation intended for reconstitution to form a suspension for parenteral use which 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).	a,b	INJ PWD F/SUSP ER	710	C42977
INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION	A sterile freeze dried preparation intended for reconstitution for parenteral use which has been formulated in a manner that would 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.	a,b	INJ PWD LYO F/LS	713	C42959
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which 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.	a,b	INJ PWD LYO F/SOL	705	C42957
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION	A liquid preparation, intended for parenteral use that contains solids suspended in a suitable fluid medium 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.	a,b	INJ PWD LYO F/SUSP	706	C42958
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE	A sterile freeze dried preparation intended for reconstitution for parenteral use which 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).	a,b	INJ PWD LYO F/SUSPER	712	C42956
INJECTION, SOLUTION	A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.	a,b	INJ SOL	708	C42945
INJECTION, SOLUTION, CONCENTRATE	A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.	a,b	INJ SOL CONC	709	C42899
INJECTION, SUSPENSION	A liquid preparation, suitable for 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.	a,b	INJ SUSP	704	C42995
INJECTION, SUSPENSION, EXTENDED RELEASE	A sterile preparation intended for parenteral use which 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).	a,b	INJ SUSP ER	711	C42926
INJECTION, SUSPENSION, LIPOSOMAL	A liquid preparation, suitable for injection, which consists of an oil 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.	a,b	INJ SUSP LIPOS	714	C42951
INJECTION, SUSPENSION, SONICATED	A liquid preparation, suitable for injection, which consists of solid 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.	a	INJ SUSP SON	840	C42988
INSERT	A specially formulated and shaped non-encapsulated solid preparation intended to be placed into a non-rectal orifice of the body, where drug is released, generally for localized effects.	a,c	INSERT	853	C60933
INSERT, EXTENDED RELEASE	A specially formulated and shaped non-encapsulated solid preparation 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.	a,b,c	INSERT ER	812	C42922
INTRAUTERINE DEVICE	A device inserted and left in the uterus to prevent effective conception.	a,b,c	IUD	260	C47915
IRRIGANT	A sterile solution intended to bathe or flush open wounds or body cavities; they're used topically, never parenterally.	a,b	IRRIGANT	830	C42947
JELLY	A class of gels, which are semisolid 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.	a,b,c	JELLY	072	C42948
KIT	A packaged collection of related material.	a,b	KIT	261	C47916
LINER, DENTAL	A material applied to the inside of the dental cavity, for protection or insulation of the surface.	a,b	LINER DENTAL	316	C45413
LINIMENT	A solution or mixture of various substances in oil, alcoholic solutions of soap, or emulsions intended for external application.	a,b	LINIMENT	298	C42949
LIPSTICK	A waxy solid, usually colored cosmetic, in stick form for the lips.	a,b	LIPSTICK	265	C42952
LIQUID	A dosage form consisting of a pure chemical in its liquid¹ state. This dosage form term should not be applied to solutions.	a,b,c	LIQ	299	C42953
LIQUID, EXTENDED RELEASE	A liquid that delivers a 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.	a,b,c	LIQ ER	854	C60934
LOTION	An emulsion, liquid¹ dosage form. This dosage form is generally for external application to the skin.²	a,b,c	LOTION	300	C29167
LOTION, AUGMENTED	A lotion dosage form that enhances 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".	a,b,c	LOTION AUG	364	C60957
LOTION/SHAMPOO	A lotion dosage form which has a soap or detergent that is usually used to clean the hair and scalp; it is often used as a vehicle for dermatologic agents.	a,b,c	LOTION SHAMPOO	855	C60958
LOZENGE	A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.	a,b	LOZENGE	831	C42955
MOUTHWASH	An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.	a,b	MOUTHWASH	832	C29269
NOT APPLICABLE	The use of a dosage form term is not relevant or appropriate.	a,b,c	NOT APPLICABLE	313	C48624
OIL	An unctuous, combustible substance 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.	a,b,c	OIL	098	C42965
OINTMENT	A semisolid³ dosage form, usually 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.	a,b,c	OINTMENT	101	C42966
OINTMENT, AUGMENTED	An ointment dosage form that enhances 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".	a,b,c	OINTMENT AUG	366	C60984
PACKING	A material, usually covered by or impregnated with a drug that is inserted into a body cavity or between the tooth enamel and the gingival margin.	a,b	PACKING	839	C47887
PASTE	A semisolid³ dosage form, containing 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.	a,b,c	PASTE	103	C42967
PASTE, DENTIFRICE	A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.	a,b	PASTE DENT	104	C42907
PASTILLE	An aromatic preparation, often with a pleasing flavor, usually intended to dissolve in the mouth.	a,c	PASTILLE	341	C60985
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. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.	a,b,c	PATCH	843	C42968
PATCH, EXTENDED RELEASE	A drug delivery system in the form of a patch that releases the drug in 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).	a,b	PATCH ER	813	C42923
PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLED	A drug delivery system in the form of a patch which is controlled by an electric current that releases the drug in 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).	a,b	PATCH ER ELCON	814	C42911
PELLET	A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.	a,b,c	PELLET	105	C42969
PELLET, IMPLANTABLE	A small sterile solid mass consisting 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.	a	PELLET IMP	844	C42943
PELLETS, COATED, EXTENDED RELEASE	A solid dosage form in which the drug itself is in the form of granules to which varying amounts of coating 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.	a	PELLETS COATED ER	842	C42918
PILL	A small, round solid dosage form containing a medicinal agent intended for oral administration.	a,b	PILL	107	C25394
PLASTER	Substance intended for external 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.	a,b	PLASTER	108	C42970
POULTICE	A soft, moist mass of meal, herbs, seed, etc., usually applied hot in cloth that consists of gruel-like consistency.	a,b	POULTICE	109	C47913
POWDER	An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.	a,b,c	PWD	110	C42972
POWDER, DENTIFRICE	A powder formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.	a,b	PWD DENT	115	C42908
POWDER, FOR SOLUTION	An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.	a,b	PWD F/SOL	833	C42973
POWDER, FOR SUSPENSION	An intimate mixture of dry, finely 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).	a,b	PWD F/SUSP	834	C42975
POWDER, METERED	An powder dosage form that is situated inside a container that has a mechanism to deliver a specified quantity.	a,c	PWD MET	841	C42961
RING	A small circular object with a vacant circular center that is usually intended to be placed in the body by special inserters, where the medication is released, generally for localized effects.	a,b,c	RING	856	C60988
RINSE	A liquid used to cleanse by flushing.	a,b	RINSE	303	C42979
SALVE	A thick ointment or cerate (a fat or wax based preparation with a consistency between an ointment and a plaster).	a,b	SALVE	137	C42980
SHAMPOO	A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.	a,b,c	SHAMPOO	304	C42981
SHAMPOO, SUSPENSION	A liquid soap or detergent containing one or more solid, insoluble 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.	a,b	SHAMPOO SUSP	193	C42982
SOAP	Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.	a,b,c	SOAP	305	C42983
SOLUTION	A clear, homogeneous liquid¹ dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.	a,b,c	SOL	138	C42986
SOLUTION, CONCENTRATE	A liquid preparation (i.e., a substance 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.	a,b	SOL CONC	835	C42898
SOLUTION, FOR SLUSH	A solution for the preparation of an 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.	a,c	SOL F/SLUSH	321	C42987
SOLUTION, GEL FORMING / DROPS	A solution, which after usually being administered in a drop-wise fashion, forms a gel.	a,c	SOL GF DROPS	858	C60994
SOLUTION, GEL FORMING, EXTENDED RELEASE	A solution that forms a gel when it comes in contact with ocular fluid, and which allows at least a reduction in dosing frequency.	a	SOL GF ER	717	C42935
SOLUTION/ DROPS	A solution which is usually administered in a drop-wise fashion.	a,b,c	SOL DROPS	857	C60992
SPONGE	A porous, interlacing, absorbent material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape.	a,b,c	SPONGE	271	C47912
SPRAY	A liquid minutely divided as by a jet of air or steam.	a,b,c	SPRAY	272	C42989
SPRAY, METERED	A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.	a,b,c	SPRAY MET	345	C42962
SPRAY, SUSPENSION	A liquid preparation containing solid 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.	a,b	SPRAY SUSP	195	C42990
STICK	A dosage form prepared in a relatively long and slender often cylindrical form.	a,b	STICK	273	C42991
STRIP	A long narrow piece of material.	a,b	STRIP	274	C47914
SUPPOSITORY	A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.	a,b,c	SUPP	173	C42993
SUPPOSITORY, EXTENDED RELEASE	A drug delivery system in the form of a suppository that allows for a reduction in dosing frequency.	a,b,c	SUPP ER	815	C42924
SUSPENSION	A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.	a,b	SUSP	177	C42994
SUSPENSION, EXTENDED RELEASE	A liquid preparation consisting of solid particles dispersed throughout a 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).	a,b	SUSP ER	816	C42925
SUSPENSION/ DROPS	A suspension which is usually administered in a dropwise fashion.	a,c	SUSP DROPS	859	C60995
SUTURE	A strand or fiber used to hold wound edges in apposition during healing.	a	SUTURE	275	C47889
SWAB	A small piece of relatively flat 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.	a,b,c	SWAB	276	C47898
SYRUP	An oral solution containing high 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,b,c	SYRUP	307	C42996
TABLET	A solid dosage form containing medicinal substances with or without suitable diluents.	a,b,c	TAB	500	C42998
TABLET, CHEWABLE	A solid dosage form containing 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.	a,b,c	TAB CHEW	501	C42893
TABLET, COATED	A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.	a,b	TAB COATED	502	C42897
TABLET, COATED PARTICLES	A solid dosage form containing a conglomerate of medicinal particles that have each been covered with a coating.	a,c	TAB COATED PART	860	C60997
TABLET, DELAYED RELEASE	A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.	a,b,c	TAB DR	520	C42905
TABLET, DELAYED RELEASE PARTICLES	A solid dosage form containing a conglomerate of medicinal 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.	a,b	TAB DR PARTICLES	521	C42997
TABLET, DISPERSIBLE	A tablet that, prior to administration, is intended to be placed in liquid, where its contents will be distributed evenly throughout that liquid. Note: The term ‘tablet, dispersible’ is no longer used for approved drug products, and it has been replaced by the term ‘tablet, for suspension’.	a,c	TAB DISP	491	[Note: The concept has been entered as a synonym for the dosage form term TABLET, FOR SUSPENSION.]
TABLET, EFFERVESCENT	A solid dosage form containing 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.	a,b,c	TAB EFFRV	503	C42910
TABLET, EXTENDED RELEASE	A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.	a,b,c	TAB ER	510	C42927
TABLET, FILM COATED	A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.	a,b	TAB FILM COATED	504	C42931
TABLET, FILM COATED, EXTENDED RELEASE	A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a 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 ingestion.	a,b	TAB FILM COATED ER	511	C42930
TABLET, FOR SOLUTION	A tablet that forms a solution when placed in a liquid.	a,c	TAB FOR SOL	523	C61004
TABLET, FOR SUSPENSION	A tablet that forms a suspension when placed in a liquid (formerly referred to as a ‘dispersible tablet’).	a,c	TAB FOR SUSP	524	C61005
TABLET, MULTILAYER	A solid dosage form containing medicinal substances that have been 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.	a,b	TAB MULTILAYER	505	C42964
TABLET, MULTILAYER, EXTENDED RELEASE	A solid dosage form containing medicinal substances that have been 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, 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.	a,b	TAB MULTILAYER ER	512	C42963
TABLET, ORALLY DISINTEGRATING	A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.	a,b,c	TAB ORALLY DIS	522	C42999
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE	A solid dosage form containing medicinal substances which disintegrates 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.	a,c	TAB ORALLY DIS DR	526	C61006
TABLET, SOLUBLE	A solid dosage form that contains medicinal substances with or without suitable diluents and possesses the ability to dissolve in fluids.	a,b	TAB SOLUBLE	507	C42985
TABLET, SUGAR COATED	A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a colored or an uncolored water-soluble sugar.	a,b	TAB SUGAR COATED	508	C42992
TAMPON	A plug made of cotton, sponge, or oakum variously used in surgery to plug the nose, vagina, etc., for the control of hemorrhage or the absorption of secretions.	a,b,c	TAMPON	277	C47892
TAPE	A narrow woven fabric, or a narrow extruded synthetic (such as plastic), usually with an adhesive on one or both sides.	a,b,c	TAPE	278	C47897
TINCTURE	An alcoholic or hydroalcoholic solution prepared from vegetable materials or from chemical substances.	a,b	TINCTURE	837	C43000
TROCHE	A discoid-shaped solid containing the medicinal agent in a suitably flavored base; troches are placed in the mouth where they slowly dissolve, liberating the active ingredients.	a,b	TROCHE	363	C43001
UNASSIGNED	A dosage form has yet to be assigned.	a,b	UNASSIGNED	900	C43002
WAFER	A thin slice of material containing a medicinal agent.	a,b	WAFER	245	C43003

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 stress 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.

CDER DATA STANDARDS MANUAL