![]() The second segment, the product code, identifies a specific strength, dosage form, and formulation for a particular firm. ![]() A labeler is any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug. The first segment, the labeler code, is assigned by the FDA. This number, known as the NDC, identifies the labeler, product, and trade package size. But these deletions are not intended to contradict patent, trademark, registration, or copyright laws or regulations.Įach listed drug product listed is assigned a unique 10-digit, 3-segment number. Symbols indicating trademarked or registered products also are omitted because of computer input capabilities. But the terms "not NF" and "not USP" may have been left as part of the name. The designations, "United States Pharmacopeia" (USP) or "National Formulary" (NF) may also have been deleted from product names. For example, where strength is ordinarily listed as a component of the product name, but also appears in other data fields, the strength may have been removed from the product name. ![]() Minor editorial changes were made in some cases when information normally included with the name appears elsewhere in the product description. All product names appearing in the NDC Directory are limited to a maximum of 100 characters. The product names used in the NDC Directory are generally supplied by the manufacturer (also called “labelers” or “firms” for purposes of listing) as required under the Act. THE INCLUSION OF A FIRM OR ITS PRODUCTS IN THE NDC DIRECTORY DOES NOT DENOTE APPROVAL BY THE FDA OF THE FIRM OR ANY OF ITS MARKETED PRODUCTS, NOR IS IT A DETERMINATION THAT A PRODUCT IS A DRUG AS DEFINED BY THE ACT, NOR DOES IT DENOTE THAT A PRODUCT IS COVERED BY OR ELIGIBLE FOR REIMBURSEMENT BY MEDICARE, MEDICAID, OR OTHER PAYERS.
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