On March 5, 2026, the U.S. Food and Drug Administration (FDA) published the Revising the National Drug Code Format and Drug Label Barcode Requirements final rule. The final rule adopts a 12-digit format for the National Drug Code (NDC) consisting of three segments:
6-digit labeler code – 4-digit product code – 2-digit package code
The rule will take effect on March 7, 2033. Where the 7-year transition period is intended to give companies time to update their systems, processes, and infrastructure to handle the 12-digit NDC. During the transition period, the FDA will continue to assign 10-digit NDCs, they will only assign the 12-digit format for new NDCs on and after the effective date.
After the 7-year transition period, there will be an additional 3-year transition period beginning March 7, 2033 through March 6, 2036, to allow for labeling updates and to deplete old labeling stock. During that time, the 10-digit NDC format shall be replaced with the new 12-digit NDC format by adding leading zeros to the labeler code, product code, and/or package code segments, as appropriate. “During the three-year transition period, FDA does not intend to object to continued use of 10-digit NDCs on drug labels… Drugs labeled with a 10-digit NDC that are introduced into interstate commerce on or after March 7, 2036 may be subject to regulatory action.” It should be noted that the FDA expects that companies will ensure that their systems can handle both the 10-digit and 12-digit NDC formats during the 3-year transition period.
“FDA will automatically update all drug listing files to reflect the 12-digit NDC format on March 7, 2033. Registrants will not need to submit new or updated drug listing files for the NDC format change. Registrants are expected to update all drug listing files once drug labeling is updated to include the new 12-digit NDC.”
In addition to the NDC updates, the FDA is also updating 21 CFR 201.25 to allow for linear and nonlinear barcodes.
Background
A National Drug Code (NDC) is a unique code assigned to every drug marketed in the U.S. In 2022, the FDA proposed a rule to revise the NDC format from a 10-digit format to a 12-digit format because they were running out of 10-digit numbers that could be assigned.
Link: https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/national-drug-code-format
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