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Drugs

Dosage Form

FDA Data Element Number.  None.

CDER Data Element Number.  C-DRG-00201

Data Element Name. Dosage Form.

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 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A 1999 Food and Drug Administration Draft Guidance for Industry states: "A dosage form is the way of identifying the drug in its physical form.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."

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.

NAMEDEFINITIONUSE RESTRICTIONSSHORT NAMEFDA CODENCI CONCEPT ID
AEROSOLA 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,cAER246C42887
AEROSOL, FOAMA 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,cAER FOAM800C42888
AEROSOL, METEREDA pressurized dosage form consisting of metered dose valves which allow for the delivery of a uniform quantity of spray upon each activation.a,b,cAER MET339C42960
AEROSOL, POWDERA 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,bAER PWD801C42971
AEROSOL, SPRAYAn 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,bAER SPRAY247C42889
BAR, CHEWABLEA solid dosage form usually in the form of a rectangle that is meant to be chewed.a,b,cBAR CHEW347C42892
BEADA solid dosage form in the shape of a small ball.a,bBEAD317C42890
BEAD, IMPLANT, EXTENDED RELEASEA 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.aBEAD IMP ER802C43451
BLOCKSolid dosage form, usually in the shape of a square or rectangle.a,bBLOCK803C42891
CAPSULEA 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,cCAP600C25158
CAPSULE, COATEDA 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,bCAP COATED602C42895
CAPSULE, COATED PELLETSA 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,cCAP COATED PELLETS603C42896
CAPSULE, COATED, EXTENDED RELEASEA 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,bCAP COATED ER611C42917
CAPSULE, DELAYED RELEASEA 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,cCAP DR620C42902
CAPSULE, DELAYED RELEASE PELLETSA 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,cCAP DR PELLETS621C42904
CAPSULE, EXTENDED RELEASEA 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,cCAP ER610C42916
CAPSULE, FILM COATED, EXTENDED RELEASEA 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.aCAP FILM COATED ER612C42928
CAPSULE, GELATIN COATEDA 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,bCAP GELATIN COATED605C42936
CAPSULE, LIQUID FILLEDA 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,bCAP LIQ FILLED606C42954
CEMENTA substance that serves to produce solid union between two surfaces.aCEMENT252C45414
CIGARETTEA narrow tube of cut tobacco (or other similar material) enclosed in paper and designed for smoking.a,bCIGARETTE253C42678
CLOTHA large piece of relatively flat, absorbent material that contains a drug.  It is typically used for applying medication or for cleansing.a,b,cCLOTH845C60884
CONCENTRATEA liquid preparation of increased strength and reduced volume which is usually diluted prior to administration.a,b,cCONC280C60891
CONEA 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,bCONE049C42900
CORE, EXTENDED RELEASEAn ocular system placed in the eye from which the drug diffuses through a membrane at a constant rate over a specified period.a,bCORE ER804C42919
CREAMAn 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,cCREAM805C28944
CREAM, AUGMENTEDA 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,cCREAM AUG365C60897
CRYSTALA 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.aCRYSTAL051C42901
CULTUREThe propagation of microorganisms or of living tissue sells in special media conducive to their growth.aCULTURE281C45415
DIAPHRAGMA device usually dome-shaped, worn during copulation over the cervical mouth for prevention of conception or infection.aDIAPHRAGM255C47890
DISCA circular plate-like organ or structure.a,b,cDISC256C43525
DOUCHEA 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.aDOUCHE838C42679
DRESSINGThe application of various materials for protecting a wound.a,b,cDRESSING285C42763
DRUG DELIVERY SYSTEMModern technology, distributed with or as a part of a drug product that allows for the uniform release or targeting of drugs to the body.aDDS259C17423
ELIXIRA clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use.a,b,cELIXIR807C42912
EMULSIONA 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,cEMULSION052C42913
ENEMAA rectal preparation for therapeutic, diagnostic, or nutritive purposes.a,b,cENEMA286C42915
EXTRACTA 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,bEXTRACT287C42929
FIBER, EXTENDED RELEASEA 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,cFIBER ER847C60926
FILMA thin layer or coating.a,bFILM061C42932
FILM, EXTENDED RELEASEA 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,cFILM ER810C42920
FILM, SOLUBLEA thin layer or coating which is susceptible to being dissolved when in contact with a liquid.a,bFILM SOLUBLE063C42984
FOR SOLUTIONA product, usually a solid, intended for solution prior to administration.a,cFOR SOL848C60927
FOR SUSPENSIONA product, usually a solid, intended for suspension prior to administration.a,cFOR SUSP849C60928

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,cFOR SUSP ER850C60929
GASAny elastic aeriform fluid in which the molecules are separated from one another and so have free paths.a,b,cGAS064C42933
GELA 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,cGEL066C42934
GEL, DENTIFRICEA 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,bGEL DENT806C42906
GEL, METEREDA gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity of gel upon each activation.a,b,cGEL MET851C60930
GENERATORAn 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,bGENERATOR289C48193
GLOBULEAlso 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,bGLOBULE808C42937
GRAFTA slip of skin or of other tissue for implantation.a,bGRAFT290C45416
GRANULEA small particle or grain.a,b,cGRAN078C42938
GRANULE, DELAYED RELEASEA 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,cGRAN DR820C42903
GRANULE, EFFERVESCENTA 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,cGRAN EFFRV080C42909
GRANULE, FOR SOLUTIONA 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,bGRAN F/SOL809C42939
GRANULE, FOR SUSPENSIONA 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,bGRAN F/SUSP819C42940
GRANULE, FOR SUSPENSION, EXTENDED RELEASEA 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.aGRAN F/SUSP ER811C42921
GUMA mucilaginous excretion from various plants.a,bGUM084C42941
GUM, CHEWINGA sweetened and flavored insoluble plastic material of various shapes which when chewed, releases a drug substance into the oral cavity.a,b,cGUM CHEWING085C42894
GUM, RESINNatural mixture of gum and resin, usually obtained as exudations from plants.a,bGUM RESIN087C42978
IMPLANTA 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,cIMP715C42942
INHALANTA 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,cINHALANT293C42944
INJECTABLE, LIPOSOMALAn 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,cINJ LIPOS852C60931
INJECTIONA sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.a,bINJ700C42946
INJECTION, EMULSIONAn emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally.a,bINJ EMULSION701C42914
INJECTION, LIPID COMPLEX[definition pending]aINJ LIPID COMPLEX716C42950
INJECTION, POWDER, FOR SOLUTIONA sterile preparation intended for reconstitution to form a solution for parenteral use.a,bINJ PWD F/SOL702C42974
INJECTION, POWDER, FOR SUSPENSIONA sterile preparation intended for reconstitution to form a suspension for parenteral use.a,bINJ PWD F/SUSP703C42976
INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASEA 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,bINJ PWD F/SUSP ER710C42977
INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSIONA 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,bINJ PWD LYO F/LS713C42959
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONA 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,bINJ PWD LYO F/SOL705C42957
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSIONA 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,bINJ PWD LYO F/SUSP706C42958
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASEA 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,bINJ PWD LYO F/SUSPER712C42956
INJECTION, SOLUTIONA 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,bINJ SOL708C42945
INJECTION, SOLUTION, CONCENTRATEA 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,bINJ SOL CONC709C42899
INJECTION, SUSPENSIONA 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,bINJ SUSP704C42995
INJECTION, SUSPENSION, EXTENDED RELEASEA 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,bINJ SUSP ER711C42926
INJECTION, SUSPENSION, LIPOSOMALA 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,bINJ SUSP LIPOS714C42951
INJECTION, SUSPENSION, SONICATEDA 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.aINJ SUSP SON840C42988
INSERTA 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,cINSERT853C60933
INSERT, EXTENDED RELEASEA 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,cINSERT ER812C42922
INTRAUTERINE DEVICEA device inserted and left in the uterus to prevent effective conception.a,b,cIUD260C47915
IRRIGANTA sterile solution intended to bathe or flush open wounds or body cavities; they're used topically, never parenterally.a,bIRRIGANT830C42947
JELLYA 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,cJELLY072C42948
KITA packaged collection of related material.a,bKIT261C47916
LINER, DENTALA material applied to the inside of the dental cavity, for protection or insulation of the surface.a,bLINER DENTAL316C45413
LINIMENTA solution or mixture of various substances in oil, alcoholic solutions of soap, or emulsions intended for external application.a,bLINIMENT298C42949
LIPSTICKA waxy solid, usually colored cosmetic, in stick form for the lips.a,bLIPSTICK265C42952
LIQUIDA dosage form consisting of a pure chemical in its liquid1 state.  This dosage form term should not be applied to solutions. a,b,cLIQ299C42953
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,cLIQ ER854C60934
LOTIONAn emulsion, liquid1 dosage form.  This dosage form is generally for external application to the skin.2a,b,cLOTION300C29167
LOTION, AUGMENTEDA 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,cLOTION AUG364C60957
LOTION/SHAMPOOA 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,cLOTION SHAMPOO855C60958
LOZENGEA 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,bLOZENGE831C42955
MOUTHWASHAn aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.a,bMOUTHWASH832C29269
NOT APPLICABLEThe use of a dosage form term is not relevant or appropriate.a,b,cNOT APPLICABLE313C48624
OILAn 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,cOIL098C42965
OINTMENTA 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,cOINTMENT101C42966
OINTMENT, AUGMENTEDAn 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,cOINTMENT AUG366C60984
PACKINGA 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,bPACKING839C47887
PASTEA 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,cPASTE103C42967
PASTE, DENTIFRICEA paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.a,bPASTE DENT104C42907
PASTILLEAn aromatic preparation, often with a pleasing flavor, usually intended to dissolve in the mouth.a,cPASTILLE341C60985
PATCHA 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,cPATCH843C42968
PATCH, EXTENDED RELEASEA 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,bPATCH ER813C42923
PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLEDA 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,bPATCH ER ELCON814C42911
PELLETA 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,cPELLET105C42969
PELLET, IMPLANTABLEA 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.aPELLET IMP844C42943
PELLETS, COATED, EXTENDED RELEASEA 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.aPELLETS COATED ER842C42918
PILLA small, round solid dosage form containing a medicinal agent intended for oral administration.a,bPILL107C25394
PLASTERSubstance 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,bPLASTER108C42970
POULTICEA soft, moist mass of meal, herbs, seed, etc., usually applied hot in cloth that consists of gruel-like consistency.a,bPOULTICE109C47913
POWDERAn intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.a,b,cPWD110C42972
POWDER, DENTIFRICEA powder formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.a,bPWD DENT115C42908
POWDER, FOR SOLUTIONAn intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.a,bPWD F/SOL833C42973
POWDER, FOR SUSPENSIONAn 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,bPWD F/SUSP834C42975
POWDER, METEREDAn powder dosage form that is situated inside a container that has a mechanism to deliver a specified quantity.a,cPWD MET841C42961
RINGA 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,cRING856C60988
RINSEA liquid used to cleanse by flushing.a,bRINSE303C42979
SALVEA thick ointment or cerate (a fat or wax based preparation with a consistency between an ointment and a plaster).a,bSALVE137C42980
SHAMPOOA liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.a,b,cSHAMPOO304C42981
SHAMPOO, SUSPENSIONA 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,bSHAMPOO SUSP193C42982
SOAPAny 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,cSOAP305C42983
SOLUTIONA clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.a,b,cSOL138C42986
SOLUTION, CONCENTRATEA 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,bSOL CONC835C42898
SOLUTION, FOR SLUSHA 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,cSOL F/SLUSH321C42987
SOLUTION, GEL FORMING / DROPSA solution, which after usually being administered in a drop-wise fashion, forms a gel.a,cSOL GF DROPS858C60994
SOLUTION, GEL FORMING, EXTENDED RELEASEA solution that forms a gel when it comes in contact with ocular fluid, and which allows at least a reduction in dosing frequency.aSOL GF ER717C42935
SOLUTION/ DROPSA solution which is usually administered in a drop-wise fashion.a,b,cSOL DROPS857C60992
SPONGEA 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,cSPONGE271C47912
SPRAYA liquid minutely divided as by a jet of air or steam.a,b,cSPRAY272C42989
SPRAY, METEREDA non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.a,b,cSPRAY MET345C42962
SPRAY, SUSPENSIONA 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,bSPRAY SUSP195C42990
STICKA dosage form prepared in a relatively long and slender often cylindrical form.a,bSTICK273C42991
STRIPA long narrow piece of material.a,bSTRIP274C47914
SUPPOSITORYA 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,cSUPP173C42993
SUPPOSITORY, EXTENDED RELEASEA drug delivery system in the form of a suppository that allows for a reduction in dosing frequency.a,b,cSUPP ER815C42924
SUSPENSIONA liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.a,bSUSP177C42994
SUSPENSION, EXTENDED RELEASEA 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,bSUSP ER816C42925
SUSPENSION/ DROPSA suspension which is usually administered in a dropwise fashion.a,cSUSP DROPS859C60995
SUTUREA strand or fiber used to hold wound edges in apposition during healing.aSUTURE275C47889
SWABA 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,cSWAB276C47898
SYRUPAn 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,cSYRUP307C42996
TABLETA solid dosage form containing medicinal substances with or without suitable diluents.a,b,cTAB500C42998
TABLET, CHEWABLEA 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,cTAB CHEW501C42893
TABLET, COATEDA solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.a,bTAB COATED502C42897
TABLET,
COATED PARTICLES
A solid dosage form containing a conglomerate of medicinal particles that have each been covered with a coating.a,cTAB COATED PART860C60997
TABLET, DELAYED RELEASEA 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,cTAB DR520C42905
TABLET, DELAYED RELEASE PARTICLESA 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,bTAB DR PARTICLES521C42997
TABLET, DISPERSIBLEA 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,cTAB DISP491[Note: The concept has been entered as a synonym for the dosage form term TABLET, FOR SUSPENSION.]
TABLET, EFFERVESCENTA 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,cTAB EFFRV503C42910
TABLET, EXTENDED RELEASEA 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,cTAB ER510C42927
TABLET, FILM COATEDA 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,bTAB FILM COATED504C42931
TABLET, FILM COATED, EXTENDED RELEASEA 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,bTAB FILM COATED ER511C42930
TABLET, FOR SOLUTIONA tablet that forms a solution when placed in a liquid.a,cTAB FOR SOL523C61004
TABLET, FOR SUSPENSIONA tablet that forms a suspension when placed in a liquid (formerly referred to as a ‘dispersible tablet’).a,cTAB FOR SUSP524C61005
TABLET, MULTILAYERA 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,bTAB MULTILAYER505C42964
TABLET, MULTILAYER, EXTENDED RELEASEA 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,bTAB MULTILAYER ER512C42963
TABLET, ORALLY DISINTEGRATINGA solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.a,b,cTAB ORALLY DIS522C42999
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASEA 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,cTAB ORALLY DIS DR526C61006
TABLET, SOLUBLEA solid dosage form that contains medicinal substances with or without suitable diluents and possesses the ability to dissolve in fluids.a,bTAB SOLUBLE507C42985
TABLET, SUGAR COATEDA 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,bTAB SUGAR COATED508C42992
TAMPONA 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,cTAMPON277C47892
TAPEA narrow woven fabric, or a narrow extruded synthetic (such as plastic), usually with an adhesive on one or both sides.a,b,cTAPE278C47897
TINCTUREAn alcoholic or hydroalcoholic solution prepared from vegetable materials or from chemical substances.a,bTINCTURE837C43000
TROCHEA 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,bTROCHE363C43001
UNASSIGNEDA dosage form has yet to be assigned.a,bUNASSIGNED900C43002
WAFERA thin slice of material containing a medicinal agent.a,bWAFER245C43003

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. 

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