21 CFR 201.2 - Drugs and devices; National Drug Code numbers.

Regulations last checked for updates: Feb 10, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart A [§ 201.1 - § 201.26]

§ 201.2 - Drugs and devices; National Drug Code numbers.

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.

[40 FR 52002, Nov. 7, 1975, as amended at 81 FR 60212, Aug. 31, 2016]

authority: 21 U.S.C. 321,331,343,351,352,353,355,358,360,360b,360ccc,360ccc-1,360ddd,360ddd-1,360ee,360gg-360ss,371,374,379e; 42 U.S.C. 216,241,262,264

source: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.

cite as: 21 CFR 201.2