FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Stakeholders Offer Feedback on New National Drug Code Format

Jan. 18, 2019
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The FDA is considering new formats to replace the five-digit National Drug Code (NDC) and drugmakers — at least those who commented on the agency’s proposals — prefer extending the code to 12 digits.

Last November, the FDA noted that it will run out of five-digit NDC numbers in coming years and it suggested four possible options, but left the door open for other ideas.

In addition to maintaining the existing format for now, the FDA also floated announcing a date to begin assigning six-digit codes, transitioning to six-digit labeling once the five-digit code is exhausted, and introducing a new, expanded 12-digit format to which existing NDCs would be converted.

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