C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 201—LABELING › Subpart A—General Labeling Provisions

21 C.F.R. § 201.2

Drugs and devices; National Drug Code numbers

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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]
Notes of Decisions
Cited in 2 cases (1 in the last 5 years), 2005–2025 · leading case: Servier Pharm. LLC. v. Becerra (D.D.C. 2025).
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Servier Pharm. LLC. v. Becerra (D.D.C. 2025). “” 21 C.F.R. § 201.2 . 13 At issue in this case is Servier’s third drug, Tibsovo.”
In Re Canadian Imp. Antitrust Litig., 385 F. Supp. 2d 930 (D. Minnesota 2005). “See 21 C.F.R. §§ 201.2 , 207.35(b)(2). Plaintiffs contend, without citation to authority, that section 353(b)(2) exempts drugs dispensed by a Canadian pharmacist from these requirements.”
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