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
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| What is the National Drug Code System? |
| What products are included in the Directory? |
| What are the components of the NDC? |
| How current is the Data? |
| Can I get NDC Directory electronic files? |
What is the National Drug Code System?
The 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 Drug Listing Act of 1972, amending the Federal Food, Drug, and Cosmetic Act, became effective February 1, 1973. Its purpose is to provide the Commissioner of the Food and Drug Administration (FDA) a current list of all drugs manufactured, prepared, propagated, compounded, or processed by a drug establishment registered under the Federal Food, Drug, and Cosmetic Act. The act requires submission of information on commercially marketed drugs and is used in the enforcement of the Federal Food, Drug, and Cosmetic Act.
The Drug Registration and Listing System (DRLS) Instruction Booklet describes in detail the registration and listing process and also contains the applicable Code of Federal Regulations (CFR).
What products are included in the Directory?The directory consists of prescription and selected over-the-counter, insulin, domestic, and foreign drug products that are in commercial distribution in the United States. The products have been listed in accordance with the Drug Listing Act and applicable Code of Federal Regulations for submitting drug product information to the FDA.
There are a number of reasons why products may not be included in the directory (and be in your medicine cabinet):
What are the components of the 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 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.
For consistency, other Government agencies may display the NDC in an eleven digit format. For example, the Centers for Medicare and Medicaid Services (CMMS) displays the labeler code as 5 digits with leading zeros; the product code as 4 digits with leading zeros; the package size as 2 characters with leading zeros.
The data is updated quarterly within 5 working days after the end of March, June, September, and December
.Can I get NDC Directory electronic files?
There are electronic data files of currently marketed products. The file layout description describes the files content. The ZIPTEXT.EXE file is a zipped executable file that can be downloaded and, using a PC database management system such as Access, be formatted for query and reporting.
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NDC Directory
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FDA/Center for Drug Evaluation and Research
Last Updated: September 19, 2002
Originator: OTCOM/DLIS
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