Revised or Reassigned NDC
For a change only in the trade package, firms may revise the Package Code segment without assigning a new Product Code segment.
-
Inform the FDA of the new NDC and packaging
Firms may reassign the NDC code for a discontinued drug to a new drug.
-
A product code may be reassigned 5 years after the expiration date of the discontinued drug, or 5 years after its last shipment into commercial distribution
-
Reuse of product codes may occur regardless of the NDC, product code, and package code configuration used
Click NEXT to continue.
Click CLOSE to return to the course.
