StacksVerified U.S. regulatory reference

21 CFR §201.50

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)The label of prescription and insulin-containing drugs in package form shall bear as one of its principal features a statement of the identity of the drug.
  2. (b)Such statement of identity shall be in terms of the established name of the drug. In the case of a prescription drug that is a mixture and that has no established name, the requirement for statement of identity shall be deemed to be satisfied by a listing of the quantitative ingredient information as prescribed by § 201.10.
  3. (c)The statement of identity of a prescription drug shall also comply with the placement, size and prominence requirements of § 201.10.