National Drug Code

The National Drug Code (NDC) is a unique identifier for a drug product. It is a 10-digit code that is assigned to a drug product by the FDA.

Format

12345-6789-0

• 12345: Manufacturer code (12345 is the manufacturer code for the drug product)
• 6789: Product code (unique within a manufacturer)
• 0: Package code (bottle of 100 tablets)

3 FDA-assigned formats currently in use:

• 4-4-2
• 5-3-2
• 5-4-1

HIPAA format

HIPAA adopted a uniform 11-digit NDC format that is required to be used when a HIPAA-covered entity transmits a claim for a drug or biological product. This is a standardized 5-4-2 format (12345-6789-01). An FDA-assigned 10-digit NDC is converted to the HIPAA format by adding a leading zero to the 10-digit NDC.

Manufacturer codes

Under 21 CFR 207.33, once the FDA runs out of 5-digit labeler codes, it will start assigning 6-digit labeler codes. NDCs with 6-digit manufacturer codes are not yet in use, but would be in the following formats: 6-3-2 or 6-4-1.

• https://www.federalregister.gov/documents/2022/07/25/2022-15414/revising-the-national-drug-code-format-and-drug-label-barcode-requirements
• https://www.fda.gov/drugs/drug-approvals-and-databases/proposed-rule-revising-national-drug-code-format