We have several OTC products that we are commericializing in bottle of different counts. We have a concern like can we keep NDC code on the outer carton only and remove from the inner bottle label?
As per the CFR regulation 21 Title CFR 201.2, "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." but our concern is specifically for the consistency of presence of NDC code on outer and inner labels for a bottle.
Is NDC code required to appear on both 'bottle carton' and 'label' of same bottle?
Question posted by Sunny Pawa on 24 Feb 2014
Last updated on 12 August 2014 by Joanne19335
Answers
Joanne19335
12 Aug 2014
If an NDC number appears on the carton, it must match the same NDC number on the bottle. You should not remove the NDC number from the bottle. This would render the drug as non-saleable (tampered with). There are serious FDA penalties for doing this.
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