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Dosage Form FDA Data Element Number Home Drugs Development & Approval Process (Drugs) Forms & Submission Requirements Electronic Submissions to CDER Data Standards Manual (monographs) Drugs Dosage Form FDA Data Element Number. None. CDER Data Element Number. C-DRG-00201 Data Element Name. 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 A 1999 Food and Drug Administration Draft Guidance for Industry states: "A dosage form is the way of identifying the drug in its physical form.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. USE SHORT FDA NCI NAME DEFINITION RESTRICTIONS NAME CODE CONCEPT ID AEROSOL A product that is packaged under a,b,c AER 246 C42887 pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols). AEROSOL, FOAM A dosage form containing one or a,b,c AER FOAM 800 C42888 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. AEROSOL, A pressurized dosage form consisting a,b,c AER MET 339 C42960 METERED of metered dose valves which allow for the delivery of a uniform quantity of spray upon each activation. AEROSOL, A product that is packaged under a,b AER PWD 801 C42971 POWDER pressure and contains therapeutically active ingredients, in the form of a powder, that are released upon activation of an appropriate valve system. AEROSOL, SPRAY An aerosol product which utilizes a a,b AER SPRAY 247 C42889 compressed 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. BAR, CHEWABLE A solid dosage form usually in the a,b,c BAR CHEW 347 C42892 form of a rectangle that is meant to be chewed. BEAD A solid dosage form in the shape of a a,b BEAD 317 C42890 small ball. BEAD, IMPLANT, A small sterile solid mass consisting a BEAD IMP ER 802 C43451 EXTENDED of a highly purified drug intended for RELEASE implantation in the body which would allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form. BLOCK Solid dosage form, usually in the a,b BLOCK 803 C42891 shape of a square or rectangle. CAPSULE A solid oral dosage form consisting of a,b,c CAP 600 C25158 a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed. CAPSULE, A solid dosage form in which the druga,b CAP COATED602 C42895 COATED is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated coating. CAPSULE, A solid dosage form in which the druga,b,c CAP COATED603 C42896 COATED PELLETS is enclosed within either a hard or PELLETS soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which varying amounts of coating have been applied. CAPSULE, A solid dosage form in which the druga,b CAP COATED611 C42917 COATED, is enclosed within either a hard or ER EXTENDED soft soluble container or "shell" made RELEASE from a suitable form of gelatin; additionally, the capsule is covered in a designated coating, and which releases a drug (or drugs) in such a manner to allow at least a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. CAPSULE, A solid dosage form in which the druga,b,c CAP DR 620 C42902 DELAYED RELEASEis enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms. CAPSULE, A solid dosage form in which the druga,b,c CAP DR 621 C42904 DELAYED RELEASEis enclosed within either a hard or PELLETS PELLETS soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines. CAPSULE, A solid dosage form in which the druga,b,c CAP ER 610 C42916 EXTENDED is enclosed within either a hard or RELEASE soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. CAPSULE, FILM A solid dosage form in which the druga CAP FILM 612 C42928 COATED, is enclosed within either a hard or COATED ER EXTENDED soft soluble container or "shell" made RELEASE from a suitable form of gelatin; additionally, the capsule is covered in a designated film coating, and which releases a drug (or drugs) in such a manner to allow at least a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. CAPSULE, A solid dosage form in which the druga,b CAP GELATIN605 C42936 GELATIN COATED is enclosed within either a hard or COATED soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal. CAPSULE, LIQUID A solid dosage form in which the druga,b CAP LIQ 606 C42954 FILLED is enclosed within a soluble, gelatin FILLED shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle. CEMENT A substance that serves to produce a CEMENT 252 C45414 solid union between two surfaces. CIGARETTE A narrow tube of cut tobacco (or a,b CIGARETTE 253 C42678 other similar material) enclosed in paper and designed for smoking. CLOTH A large piece of relatively flat, a,b,c CLOTH 845 C60884 absorbent material that contains a drug. It is typically used for applying medication or for cleansing. CONCENTRATE A liquid preparation of increased a,b,c CONC 280 C60891 strength and reduced volume which is usually diluted prior to administration. CONE A solid dosage form bounded by a a,b CONE 049 C42900 circular base and the surface formed by line segments joining every point of the boundary of the base to a common vertex. A cone (usually containing antibiotics) is normally placed below the gingiva after a dental extraction. CORE, EXTENDED An ocular system placed in the eye a,b CORE ER 804 C42919 RELEASE from which the drug diffuses through a membrane at a constant rate over a specified period.
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