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  5. National Drug Code Format
  1. Electronic Drug Registration and Listing System (eDRLS)

National Drug Code Format

FDA’s final rule, Revising the National Drug Code Format and Drug Label Barcode Requirements, adopts a uniform, 12-digit format for the national drug code (NDC). The NDC is an FDA standard for uniquely identifying drugs marketed in the U.S. Currently, the NDC assigned by FDA for each listed drug marketed in the U.S. is a unique 10-digit number and can be in several different formats.

The rule takes effect on March 7, 2033. On the effective date, FDA will assign new 12-digit NDCs and convert all previously assigned 10-digit NDCs to the uniform 12-digit NDC format. This change will impact NDCs assigned by FDA to human drugs, including biological products and animal drugs. This rule affects only FDA-assigned NDCs. It does not make any changes to NDCs formats that are used for other purposes unrelated to FDA (e.g., the HIPAA standard 11-digit format used for reimbursement).

During the seven-year period before the rule takes effect (March 5, 2026 – March 6, 2033), FDA will continue to assign 10-digit NDCs in the current formats. Manufacturers, distributors, repackagers, relabelers, pharmacies, health care providers, payors and other supply chain partners should use this time to update their systems, processes and infrastructure to handle the 12-digit NDC format by March 7, 2033.

The seven-year period before the rule takes effect is also intended to provide companies with sufficient time to update their labeling to ensure that updated labeling with NDCs in the new 12-digit format are ready for use on the effective date.

Transition period for drug labeling updates 

There will be a three-year transition period beginning March 7, 2033 through March 6, 2036 to allow time to complete label updates and deplete old labeling stock. During the three-year transition period, FDA does not intend to object to continued use of 10-digit NDCs on drug labels.

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. 

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.

Updating systems 

The agency encourages manufacturers, distributors, pharmacies, health care providers, payors, other supply chain partners, government agencies and other affected parties to begin preparing as soon as possible for the transition to 12-digit NDCs on March 7, 2033. 

Affected parties should ensure their systems are capable of handling the 10-digit and 12-digit NDC formats during the three-year transition period (March 7, 2033 – March 6, 2036). 

Drug Supply Chain Security Act and barcode requirements

Under the rule, linear or nonlinear barcode formats may be used to encode the NDC if the barcode conforms to FDA recognized standards developed by a widely recognized international standards development organization (e.g., GS1).

For purposes of complying with DSCSA product identifier requirements, a 2D data matrix barcode can encode the 12-digit NDC using GS1's application identifier 715, along with the other required data elements, including the product’s serial number, lot number and expiration date. For products subject to the NDC barcode label requirement and DSCSA product identifier requirements, a single 2D data matrix barcode may satisfy both sets of requirements beginning March 7, 2033.

Drug listing 

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. 

Exceptions to the 12-digit NDC format

Certain biologics (certain specified human cells, tissues and cellular and tissue-based products) may continue to use an alternative NDC format approved by FDA. 

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