Home › 2026-04368
Revising the National Drug Code Format and Drug Label Barcode Requirements
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)
Summary (from the Federal Register abstract)
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.
- Document type
- Rule
- Federal Register document number
- 2026-04368
- Published
- Mar 5, 2026
- Action
- Final rule.
- Docket
- FDA-2021-N-1351
- Comments posted on Regulations.gov (at last check)
- 0
- RIN
- 0910-AI52
- CFR parts
- 21 CFR 201, 21 CFR 207
- DATES section (from the document)
- This rule is effective March 7, 2033.
- Topics (auto-tagged)
- Other FDA topics
Source: Federal Register API, document 2026-04368. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.