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A 1999 Food and Drug Administration Draft Guidance for Industry states: "A dosage form is the way of identifying the drug in its physical form.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