U.S. Food and Drug Administration • Center for Drug Evaluation
and Research |
U.S. Food and Drug Administration • Center for Drug Evaluation
and Research |
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Drug Information |
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National Drug Code Directory QueryIntroduction The National Drug Code (NDC) System was originally established as an essential part of an out-of-hospital drug reimbursement program under Medicare. The NDC serves as a universal product identifier for human drugs. The National Drug Code Query (NDCQ) content is limited to prescription drugs and a few selected OTC products. The Federal Food, Drug, and Cosmetic Act requires
submission of product information on commercially distributed drugs. The Code of Federal Regulations,
21 CFR 207, describes
the listing process. The NDCQ contains drug products that have completed
the listing process in accordance with the applicable federal law. The
information is as reported by the listing firm. ORGANIZATION OF THE DIRECTORY CONTENT DESCRIPTION Trade Name (Proprietary Name) The product names used in the NDCQ are generally those supplied by the labelers (firms). All product names have been limited to a maximum of 100 characters. Minor editorial changes were made in some instances where information normally included with the name appears elsewhere in the product description. 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. The designations, "United States Pharmacopeia" (USP) or "National Formulary" (NF) may also have been deleted from product names. Occasionally, however, the term "not NF" and "not USP" have been left as part of the name. Symbols indicating trademarked or registered products also had to be omitted because of computer input capabilities. These deletions are not intended in any way to deprive the labeler of the protection afforded to him under patent, trademark, registration, or copyright laws or regulations. National Drug Code (NDC) Each drug product listed under Section 510 of the Federal Food, Drug, and Cosmetic Act is assigned a unique 10-digit, 3-segment number. This number, known as the National Drug Code (NDC), identifies the labeler/vendor, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures, repacks or distributes a drug product. The second segment, the product code, identifies a specific strength, dosage form, and formulation for a particular firm. The third segment, the package code identifies package sizes. Both the product and package codes are assigned by the firm. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1. Dosage Form The dosage form is a ten character abbreviation. Multiple dosage forms are concatenated. The abbreviation description may be found by clicking on the Query Dosage Form column heading. Active Ingredient(s) The active ingredients of the product. Multiple ingredients are listed alphabetically. Strength and Unit The strength and unit of the active ingredient. For those products which have equivalent ingredients the strength expressed is that of the equivalent. For some combination products, the strength is that which is commonly recognized for that formulation. The product itself also has a strength/unit. For products with a single active ingredient it is the strength of that active ingredient. For multiple active ingredient products, the strength is either "COMBO" or a concatenation of the multiple strengths. Package Size and Type The package size and type for the NDC. The abbreviation description for the package type may be found by clicking on the Packtype column heading. Every effort has been made to prevent errors and discrepancies in the NDCD data. Users who detect any errors are requested to email DRUGPRODUCTS@CDER.FDA.GOV Requests for more specific drug product information should be submitted in writing or directed to FDA's Freedom of Information Staff at:
FDA/Center for Drug Evaluation and Research |
