On March 5, 2026, the Food and Drug Administration (FDA) published a Final Rule adopting a new format for the National Drug Code (NDC). The rule takes effect on March 7, 2033. On the effective date, the FDA will assign new 12-digit NDCs and convert all previously assigned 10-digit NDCs to the uniform 12-digit NDC format.

What is the NDC?

The NDC is an FDA standard for uniquely identifying drugs marketed in the U.S. Currently, the NDC assigned by the FDA for each listed drug marketed in the U.S. is a unique 10-digit number and can be in several different formats.

Current formats:

10-digit identifier

The FDA’s standard NDC is a 10-digit numerical identifier that includes a labeler code, product code, and package code.

There are 3 FDA-assigned formats for the standard NDC:

  • 4-4-2
  • 5-3-2
  • 5-4-1

HIPAA Format

The Health Insurance Portability and Accountability Act (HIPAA) adopted a uniform 11-digit NDC format that must be used when a HIPAA-covered transaction includes an NDC. This 11-digit format is standardized into a 5-4-2 format and created by adding a leading zero to either the labeler, product, or package code.

Upcoming 6-Digit Format

The FDA will run out of 5-digit labeler codes in 10-15 years. Per FDA regulations (21 CFR 207.33), once the FDA runs out of 5-digit labeler codes, it will start assigning 6-digit labeler codes. Without this proposed change, there would be five NDC formats, 3 in 10- digits and 2 in 11-digits. There may be confusion between an FDA-assigned 11-digit NDC and a HIPAA converted 11-digit NDC.

The New NDC Standard

The Final Rule modifies existing regulations to establish a uniform, 12-digit format that can accommodate longer NDCs once the FDA begins issuing 6-digit labeler codes.

The change will impact a variety of industries and stakeholders, including:

  • Human and animal drug manufacturers and distributors
  • Drug importers
  • Federal agencies using the NDC
  • Drug databanks
  • Pharmacies
  • Hospitals, clinics, labs, healthcare practitioners
  • Nursing care facilities
  • Electronic health record vendors
  • State and local governments
  • Various supply chain stakeholders

The rule change standardizes the NDC format across all sectors and minimizes confusion and medication errors.

During the seven years before the rule takes effect (March 5, 2026 – March 6, 2033), the FDA will continue to assign 10-digit NDCs in the current formats. Manufacturers, distributors, repackagers, relabelers, pharmacies, health care providers, payors, and other supply chain partners should use this time to update their systems, processes, and infrastructure to handle the 12-digit NDC format by March 7, 2033.

Diaz Trade Law will continue to monitor developments concerning this proposed rule. We provide guidance on a variety of FDA matters, including food, cosmetics, drugs, alcohol, medical devices, and more.

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