Background:
The Food and Drug Administration oversees the National Drug Code (NDC) System, a directory of select OTC and prescription drug products. Pharmaceutical manufacturers register unique NDC’s in the directory to identify each of their drug products. Manufacturers are required to update their NDC registrations to remove expired products and register new ones.
Drugs listed in the NDC are identified by an 11-digit number divided into three segments. The first segment, assigned by the FDA, identifies the vendor (or labeler) involved with the manufacturing, packaging, or distribution of the drug. The manufacturer assigns the second and third segments of the code for a given product. Product codes in the second segment describe the generic entity, strength, and dosage form. The third segment, or package code, indicates the package size.
Wholesale distributors order products from manufacturers by NDC.
Wholesale distributors may order similar products such as analgesics, muscle relaxants, and antidepressants from multiple manufacturers, each having unique NDC’s.
Hospitals, clinics, pharmacies and doctors (generally “dispensers”) may order similar analgesics, muscle relaxants, and antidepressants by brand name from multiple wholesale distributors.
The DEA requires CS Registrant manufacturers and distributors to report suspicious orders of controlled substances.
Narcotic analgesics with different NDC’s or brand names can contain the same active ingredient such as hydrocodone, oxycodone or tramadol. Excessive quantities destined for illegal markets are difficult to detect.
If orders are placed by a buyer according to NDC or brand name, it is possible an excessive amount of a CS II-V drug could be ordered unnoticed and be diverted undetected to illegal markets.
Today’s DEA Blog Questions:
- How does your CS II-V order management system monitor suspicious orders of multiple NDC’s within the same drug family?
- Does your system cross reference NDC’s to the Generic Product Identifier for the active ingredient?
- Should the FDA or DEA develop standards for cross referencing NDA’s and active ingredients of concern?


