Data / Federal rules / 2026-04368
Revising the National Drug Code Format and Drug Label Barcode Requirements
The Food and Drug Administration published this final rule in the Federal Register on March 5, 2026. It takes effect on March 7, 2033.
SpecStream is the live web data engine for teams and agents. It reads every rule and proposed rule in the Federal Register each morning, and this page is that reading. Name your industry once and new rules, comment deadlines and effective dates arrive in your sheet, CRM, Slack or agent as they are published.
What the agency says
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.
Key facts
- Document number
- 2026-04368
- Type
- Final rule
- Action
- Final rule
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- March 5, 2026
- Takes effect
- March 7, 2033
- Dates
- This rule is effective March 7, 2033.
- Docket
- Docket No. FDA-2021-N-1351
- Regulation ID (RIN)
- 0910-AI52
- Code of Federal Regulations
- 21 CFR 201; 21 CFR 207
- Topics
- Drugs; Labeling; Reporting and recordkeeping requirements
- Pages
- 23
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on drugs · Rules on labeling · Rules on reporting and recordkeeping requirements · Published in March 2026
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.