On March 5, 2026, the Meals and Drug Administration (FDA) printed a Ultimate Rule adopting a brand new format for the Nationwide Drug Code (NDC). The rule takes impact on March 7, 2033. On the efficient date, the FDA will assign new 12-digit NDCs and convert all beforehand assigned 10-digit NDCs to the uniform 12-digit NDC format.
What’s the NDC?
The NDC is an FDA customary for uniquely figuring out medication marketed within the U.S. At the moment, the NDC assigned by the FDA for every listed drug marketed within the U.S. is a singular 10-digit quantity and may be in a number of completely different codecs.
Present codecs:
10-digit identifier
The FDA’s customary NDC is a 10-digit numerical identifier that features a labeler code, product code, and package deal code.
There are 3 FDA-assigned codecs for the usual NDC:
HIPAA Format
The Well being Insurance coverage Portability and Accountability Act (HIPAA) adopted a uniform 11-digit NDC format that have to be used when a HIPAA-covered transaction consists of an NDC. This 11-digit format is standardized right into a 5-4-2 format and created by including a number one zero to both the labeler, product, or package deal code.
Upcoming 6-Digit Format
The FDA will run out of 5-digit labeler codes in 10-15 years. Per FDA rules (21 CFR 207.33), as soon as the FDA runs out of 5-digit labeler codes, it can begin assigning 6-digit labeler codes. With out this proposed change, there can be 5 NDC codecs, 3 in 10- digits and a pair of in 11-digits. There could also be confusion between an FDA-assigned 11-digit NDC and a HIPAA transformed 11-digit NDC.
The New NDC Customary
The Ultimate Rule modifies current rules to ascertain a uniform, 12-digit format that may accommodate longer NDCs as soon as the FDA begins issuing 6-digit labeler codes.
The change will impression quite a lot of industries and stakeholders, together with:
Human and animal drug producers and distributors
Drug importers
Federal businesses utilizing the NDC
Drug databanks
Pharmacies
Hospitals, clinics, labs, healthcare practitioners
Nursing care amenities
Digital well being file distributors
State and native governments
Numerous provide chain stakeholders
The rule change standardizes the NDC format throughout all sectors and minimizes confusion and drugs errors.
Through the seven years earlier than the rule takes impact (March 5, 2026 – March 6, 2033), the FDA will proceed to assign 10-digit NDCs within the present codecs. Producers, distributors, repackagers, relabelers, pharmacies, well being care suppliers, payors, and different provide chain companions ought to use this time to replace their methods, processes, and infrastructure to deal with the 12-digit NDC format by March 7, 2033.
Diaz Commerce Regulation will proceed to watch developments regarding this proposed rule. We offer steerage on quite a lot of FDA issues, together with meals, cosmetics, medication, alcohol, medical gadgets, and extra.
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