FDA Moves to Standardize National Drug Code (NDC) with New 12-Digit Format

The U.S. Food and Drug Administration (FDA) has announced a significant update to the National Drug Code (NDC) system, proposing a transition to a single, uniform 12-digit format. This move is designed to modernize the drug listing process, accommodate an increasing number of manufacturers, and reduce the risk of medication errors caused by the current variety of 10- and 11-digit configurations.

For decades, the NDC has served as the universal product identifier for drugs in the United States. However, the existing 10-digit system uses three different segment configurations (4-4-2, 5-3-2, and 5-4-1), which often requires stakeholders to convert codes into a standard 11-digit format for HIPAA-covered electronic transactions. The new FDA proposal seeks to eliminate this complexity by establishing a permanent 6-4-2 structure:

• 6 digits for the Labeler Code
• 4 digits for the Product Code
• 2 digits for the Package Code

Impact on Pharmacy Technology and Management

For pharmacy owners and technology providers, this update represents a major shift in data management and software requirements. As the FDA nears the exhaustion of its current 5-digit labeler code supply, the expansion to 12 digits ensures the system can support new market entrants for the foreseeable future.

By adopting a single format, the FDA aims to eliminate the need for manual code conversions that currently drive up healthcare costs and create opportunities for dispensing errors.

Implementation Timeline

Recognizing the extensive technical updates required for pharmacy management systems (PMS), wholesalers, and payers, the FDA has proposed a phased implementation:

• Effective Date: 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. 
• Transition Period: A subsequent three-year transition period will allow firms to update product labeling. During this time, the FDA intends to maintain and publish both 10-digit and 12-digit formats to assist stakeholders in the migration.

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. 

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.

For more information on the electronic Drug Registration and Listing System (eDRLS) and specific formatting guidelines, visit the FDA's site. PTMR