subpart_subject: "Labeling Requirements for Prescription Drugs and/or Insulin"
section_number: "201.50"
section_subject: "Statement of identity."
cfr_reference: "21 CFR 201.50"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 200 to 299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.