FDA Final Rule: Preparing for the Transition to a 12-Digit NDC

What’s Changing?

Currently, FDA assigns 10-digit NDCs in multiple formats. Beginning March 7, 2033, FDA will:

• Assign all new NDCs in a 12-digit format
• Automatically convert all existing 10-digit NDCs to 12 digits

This applies to human drugs (including biologics) and animal drugs. The rule affects only FDA-assigned NDCs and does
not change formats used for other purposes, such as the HIPAA 11-digit reimbursement standard.

Key Dates to Know

Now – March 6, 2033: Preparation Period

FDA will continue assigning 10-digit NDCs during this time. Stakeholders should use this window to:

• Update internal systems and databases
• Prepare labeling revisions
• Coordinate with trading partners
• Ensure infrastructure can support 12-digit NDCs

March 7, 2033: Effective Date

• FDA begins assigning 12-digit NDCs
• All existing NDCs are converted to the new format
• Drug listing files are automatically updated by FDA

March 7, 2033 – March 6, 2036: Labeling Transition Period

Companies have three years to update labeling and deplete old stock. During this period, FDA does not intend to object to continued use of 10-digit NDCs on labels.

After March 7, 2036, drugs introduced into interstate commerce with 10-digit NDCs may be subject to regulatory action.

System and Barcode Impacts

Organizations—including manufacturers, distributors, pharmacies, payors, and healthcare providers—should ensure systems can handle both 10- and 12-digit NDCs during the transition period.

The rule also aligns with DSCSA requirements:

• 2D data matrix barcodes may encode the 12-digit NDC using GS1 standards (AI 715)
• A single 2D barcode can satisfy both FDA NDC barcode and DSCSA product identifier requirements beginning March 7, 2033

This presents an opportunity to streamline labeling and serialization processes.

Drug Listing Updates

FDA will automatically convert drug listing files to the 12-digit format on the effective date. No new submission is required solely due to the format change, though listings should reflect updated labeling once revised.

Start Preparing Now

While 2033 may seem far away, updating labeling, enterprise systems, serialization processes, and supply chain integrations will take time. Early planning will reduce compliance risk and prevent last-minute disruptions.

Need support navigating the 12-digit NDC transition?

Connect with our team to assess your readiness and build a compliant, future-proof strategy well ahead of the deadline.