21 CFR 201.50 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (§ 200.5 To § 299.5) — Food And Drug Administration, Department Of Health And Human Services (Continued) (§ 200.5 To § 299.5) — Drugs: General (§ 200.5 To § 299.5) — Labeling (§ 201.1 To Appendix A To Part 201) — Labeling Requirements For Prescription Drugs And/Or Insulin (§ 201.50 To § 201.58) — Statement of identity.

(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.

(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.

(c) The statement of identity of a prescription drug shall also comply with the placement, size and prominence requirements of § 201.10.