Revising the National Drug Code Format and Drug Label Barcode Requirements

What it does

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to standardize the format of the National Drug Code (NDC). Under this final rule, all FDA-assigned NDCs will be required to be 12 digits in length with 3 distinct segments and 1 uniform format. The first segment is a 6-digit labeler code, the second segment is a 4-digit product code, and the third segment is a 2-digit package code. Additionally, we are revising the drug product barcode label requirements to permit the use of other data carriers that meet the standards of this final rule.

The Food and Drug Administration's summary, as published in the Federal Register.

What changed in the regulation

2 parts of Title 21 of the Code of Federal Regulations:

21 CFR 201, 21 CFR 207

Compared with

The Food and Drug Administration has published 103 final rules in 2026 so far, compared with 68 in all of 2025.

Counted by the Tribune from Federal Register records since Jan. 1, 2025.

Before this

No earlier Federal Register document under regulation identifier 0910-AI52 since Jan. 1, 2025.

What happens next and when

This rule is effective March 7, 2033.

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Docket FDA-2021-N-1351 on Regulations.gov
• Title 21 on eCFR

The record as published

Source: the Federal Register (public domain). The document in the Federal Register