FDA Proposed Rule on Revising the National Drug Code Format

The much anticipated Proposed Rule on Revising the National Drug Code Format was announced in the FR Vol 87, No. 141 Revising the National Drug Code. The FDA is proposing a 12 digit uniform NDC number to replace the current format of 10 digits, which when exhausted would require the addition of the 11 digit format when 5 digit labeler codes are no longer available. The new 12 digit format would consist of a 6 digit labeler code, a 4 digit product code, and a 2 digit package code. The agency’s plan is to automatically update existing 10 digit codes by adding a leading zero to the necessary fields. For example, NDC 12345-678-90 would be converted to 012345-0678-90. FDA would make these adjustments in their system after the implementation date for existing NDC’s to alleviate the burden on registrants to do so.

The proposed effective date is 5 years from publication of the final rule, with a 3 year transition period following the effective date during which both the 10 digit and 12 digit NDCs will be considered valid. This should allow industry enough time to utilize existing labels prior to implementation of the new 12 digit format.

FDA also looked at the impact on other health agencies which utilize/reference the drug product NDC number. The agency has proposed to revise the regulation to allow for not only linear and nonlinear barcodes, but also allowing for unspecified formats that advances in technology may develop in future. See the Federal Register and Proposed rule for full details.

Comments may be submitted per the instructions in the Federal Register notification.