FDA issues long-awaited final NDC rule
The US Food and Drug Administration’s (FDA) widely anticipated final rule on national drug codes (NDCs) was published on Wednesday. The rule, which will take effect on 7 March 2033, replaces the current 10-digit code, with a uniform, 12-digit format.Currently, the NDC for each drug marketed in the US is a unique 10-digit number which consists of three segments: the labeler code, the product code and the package code.
The rule aims to address an expected shortage of available codes within the next ten to fifteen years. This follows a proposed rule issued by the FDA four years ago. (RELATED: FDA announces plans to revamp national drug code, Regulatory Focus 26 July 2022)
Last month, pharmaceutical industry groups, drug manufacturers, and other stakeholders were urging the agency to finalize its proposed rule by the end of March 2026. Industry officials emphasized that a substantial lead time is necessary for the industry to prepare for and comply with the NDC rule. (RELATED: Pharma groups pressure FDA to finalize NDC rule, Regulatory Focus 18 February 2026)
In an announcement, the FDA advised manufacturers to use the interim period before the new codes take effect to update their systems, processes, and infrastructure to accommodate the 12-digit NDC format.
FDA also stated that there will be a three-year transition period from 7 March 2033 to 6 March 2036 to allow manufacturers time to update labels and deplete old labeling stock.
FDA announced that “companies should begin updating their labeling as soon as possible to replace the 10-digit NDC format with the new 12-digit NDC format by adding leading zeros to the labeler code, product code and/or package code segments as needed. Companies must start labeling products with the 12-digit NDC as soon as possible once the transition period begins on March 7, 2033.”
The agency also stated that to comply with the Drug Supply Chain Security Act (DSCSA) product identifier requirements, manufacturers must use a 2D data matrix barcode that encodes the 12-digit NDC. This barcode should include GS1's application identifier and other essential data elements, such as the product’s serial number, lot number, and expiration date.
“Certain biologics (certain specified human cells, tissues and cellular and tissue-based products) may continue to use an alternative NDC format approved by FDA.”Bottom of Form
FDA said the costs of converting current NDCs to the standardized format would include one-time cost of updating software systems and coordinating labeling updates would be $14.64 million annually ranging from $7.64 million to $22.79 million.
At a public hearing in November 2018, FDA presented the pharmaceutical industry with four options in addressing the projected shortage of codes. These were to either to continue using the 5-digit label codes until the inventory is exhausted and then move to a 6-digit format; move to a 6-digit format on a designated date; convert the current 10-digit NDC to an 11-digit format, then to a 12-digit format once the 5 -digit label codes are exhausted; or to adopt the 12-digit NDC on a designated date before the 5-digit labels codes are exhausted.
FDA said most were in favor of adopting the last option. Also, many comments advocated for a ten-year delay in complying with the final rule.
The agency also announced that the rule does not change NDC formats used for other purposes unrelated to the FDA, such as the HIPAA standard 11-digit format used for reimbursement.
Announcement; Final rule
