CDER DATA STANDARDS MANUAL

FDA Data Element Number. None.

CDER Data Element Number. C-DRG-00402

Data Element Name. Proprietary Name.

Description. This standard provides for all Proprietary Names.

Source.

Relationship. Related terms include the Center for Drug Evaluation and Research Ingredient Dictionary (CDID) ingredient name.

FDA Specifications. None.

CDER Specifications. Proprietary name shall consist of an alphanumeric term which has a maximum length restricted to 240 characters. Proprietary names are usually suggested by the CDER Labeling and Nomenclature Committee, after discussing their acceptability based upon "look alike" and "sound alike" names, and ease of association with the generic name and/or active ingredient name. Occasionally, the CDER Ingredient Dictionary may have a Proprietary name entry and associated CD number for a proprietary mixture of inactive ingredients, but generally speaking, there are no codes necessary for Proprietary names.

Representation of Proprietary Names in CDER databases is being addressed. Usually there is little problem in identifying which portion of the labeling refers to the Proprietary Name. Some circumstances, especially OTC products, cloud this distinction. A Proprietary Name Subcommittee of the NSC is currently addressing this issue.

FDA Approved Date. None.

CDER Approved Date. November 8, 1996

FDA Revised Date.

CDER Revised Date.

Data Values. Literal.

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