The National Drug Code (NDC) number is requested but not required to appear on all drug labels and in all drug labeling, including the label of any prescription drug container furnished to a consumer.
21 CFR Part 201 · Labeling
§ 201.2 Drugs and devices; National Drug Code numbers
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
FDA guidance that cites § 201.2
- CVM GFI #231 Distributor Labeling for New Animal Drugs 20 Apr 2016
- CVM GFI #45 Guideline for Uniform Labeling of Drugs for Dairy and Beef Cattle 31 Jul 1993
Amendment history
Federal Register documents that created or amended this section.
- 40 FR 52002 7 Nov 1975
- 81 FR 60212 31 Aug 2016