FDA Finalizes Rule Standardizing National Drug Code Format

FDA Final Rule Revises National Drug Code Format and Barcode Requirements

FDA has issued a final rule revising the format of the National Drug Code (NDC) and updating certain drug label barcode requirements.

The National Drug Code is a unique identifier assigned to drug products marketed in the United States. The rule aims to standardize the format to improve consistency and reduce confusion across drug labeling and data systems.

Key Changes in the Final Rule

The final rule establishes a standardized 12-digit NDC format, replacing the current system that allows several different digit configurations.

FDA indicated that the change is intended to:

• Provide a consistent format for all NDC numbers
• Improve data accuracy in drug identification systems
• Support healthcare supply chain and electronic data exchange systems

The rule also updates requirements related to drug label barcodes, which are used to support medication verification and patient safety practices.

Implementation Considerations

Drug manufacturers and labelers may need to update systems and processes related to:

• Product labeling and packaging
• Barcode generation and verification
• Internal databases and regulatory filings
• Supply chain and distribution systems

FDA indicated that transition periods will allow industry time to implement the new format.

EAS Perspective

Standardizing the NDC format may help improve consistency across regulatory, healthcare, and supply chain systems that rely on drug product identifiers.

Companies involved in drug labeling, packaging, and data management should review the final rule to understand how the updated requirements may affect their operations.

EAS will continue monitoring implementation guidance related to the revised NDC format.