A product may be deemed to be misbranded if an NDC is used:
To represent a different drug than the drug for which the NDC has been assigned, as described in § 207.33;
To denote or imply FDA approval of a drug; or
On products that are not subject to parts 207, 607 of this chapter, or 1271 of this chapter, such as dietary supplements and medical devices.
If marketing is resumed for a discontinued drug, and no changes have been made to the drug that would require a new NDC under § 207.35, the drug must have the same NDC that was assigned to it as described in § 207.33, before marketing was discontinued.
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