National Drug Code

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National Drug Code (NDC)

The Drug Listing Act of 1972[1] requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. Drug products are identified and reported using the National Drug Code (NDC), a universal product identifier for drugs intended for human use.

National Drug Code Format

The National Drug Code is a unique 10-digit, 3-segment number assigned to each medication listed under Section 510 of the U.S. Federal Food, Drug, and Cosmetic Act. The number identifies the labeler or vendor, product, and trade package size.

• The first segment, the labeler code, is assigned by the Food and Drug Administration (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.

Each item is barcoded with a Universal Product Code that begins with a 3 (UPC-A) or 03 (EAN-13). The remainder of the numbers are the NDC number, plus the check digit.

An asterisk may appear in either a product code or a package code. It simply acts as a place holder and indicates the configuration of the NDC. Since the NDC is limited to 10 digits, a firm with a 5 digit labeler code must choose between a 3 digit product code and 2 digit package code, or a 4 digit product code and 1 digit package code.

Thus, you have either a 5-4-1 or a 5-3-2 configuration for the three segments of the NDC. Because of a conflict with the HIPAA standard of an 11 digit NDC, many programs will pad the product code or package code segments of the NDC with a leading zero instead of the asterisk. For consistency, other Government agencies may display the NDC in an eleven digit format. For example, the Centers for Medicare and Medicaid Services (CMS) 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.

Since a zero can be a valid digit in the NDC, this can lead to confusion when trying to reconstitute the NDC back to its FDA standard. Example: 12345-0678-09 (11 digits) could be 12345-678-09 or 12345-0678-9 depending on the firm's configuration. By storing the segments as character data and using the * as place holders we eliminate the confusion. In the example, FDA stores the segments as 12345-*678-09 for a 5-3-2 configuration or 12345-0678-*9 for a 5-4-1 configuration.

Example

For example, a 1.5 gram tube of Denavir is labeled with NDC number 0135-0315-52. Going to the NDC Directory Search page (see external links), one clicks on Search by NDC Number. One is then presented with choices to search by Labeler Code Only or Labeler Code and Product Code.

Selecting Labeler Code Only, one would enter 00135 (remember to add the leading 0 padding). The result is that this is 1% Denavir Cream from Glaxo-Smith-Kline Consumer Health Care.

Selecting Labeler Code and Product code, one would enter 00135 in the Labeler Code box and 0315 in the Product Code box. The result is a list of the various packages that Glaxo-Smith-Kline offered 1% Denavir Cream in. And here we see that -52 is, indeed, registered as the 1.5 gram tube.