The National Drug Code (NDC) number is a unique identifier for prescription drug products. The format, as explained by the FDA below, will need to be changed in the coming years to accommodate the entry of new labelers into the U.S. market. The advanced Federal Register Notice published today (here) outlines the issues and announces a public hearing on the topic.
The NDC for each listed drug in the United States is a unique 10-digit, 3-segment number. The three segments of NDC include the labeler code, product code, and package code. A labeler code is a unique 4-, 5-, or (in the future) 6-digit number assigned by the FDA that identifies the manufacturer, repacker, relabeler, or private‑label distributor of the drug. The second segment, the product code, identifies a specific strength, dosage form, and formulation of a drug manufactured, repackaged, relabeled, or distributed by the labeler. The third segment, the package code, identifies package sizes and types. Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging. Both the product and package codes are proposed by persons submitting the drug listing information. The FDA will assign a proposed NDC if it has not been used previously, is not currently in use, and has not been reserved for future assignment to a different product. The NDC for a given drug is currently in one of the following configurations (with each number representing the number of digits in that segment): 4-4-2, 5-3-2, or 5-4-1.
There appears to be an issue with the Health Insurance Portability and Accountability Act (HIPAA) standard established for the NDC number. “The HIPAA standard 11-digit NDC format is standardized such that the labeler code is always five digits, the product code is always four digits, and the package code always two digits.” With the FDA indicating that it will need to begin using six digits for the labeler code, there is a conflict that must be resolved.
In the hearing, the FDA is asking for feedback and comments on the following questions:
- The impact of transitioning from a 5-digit labeler code to a 6-digit labeler code, including the business, economic, information technology, and medical/clinical practice impacts, and its impact on the safety and security of drug products.
- Issues associated with the current lack of NDC uniformity in the marketplace.
- What should the FDA consider as it explores any further changes or expansion to the format or length of the NDC?
- How to best transition to a new format for the NDC.
Even seemingly simple changes can cause unintended consequences, especially when drug identification impacts such varied areas as “prescribing, dispensing, reimbursement, safety, clinical management, supply chain management, and pharmaceutical manufacturing and labeling systems.” Hence the need for plenty of discussion before the FDA has to pull the trigger on a new format for the NDC number.