What Pharmacies Need to Know About FDA Shift to 12-Digit NDCs

The FDA is moving to a uniform 12-digit National Drug Code (NDC) format, and pharmacy leaders say the industry needs to start preparing now—even with a 7-year runway before the 2036 deadline.

The new 6-4-2 structure (6-digit labeler code, 4-digit product code, and 2-digit packaging code) replaces a fragmented system of 10-digit formats and addresses a growing shortage of available labeler codes. But the logistical implications run far deeper than simply adding leading zeros.

“I don't think the risk that organizations are going to face are going to be in the end state; it's going to be in the transition,” Neal Cooper, vice president of regulatory affairs and quality systems at American Health Packaging, told Drug Topics. “If industry and companies underestimate how impactful this could be and delay starting the project and the work, it's going to be a significant issue for them to solve down the road.”

Every system that touches an NDC number—dispensing platforms, adjudication systems, payer networks, inventory management tools, and bedside scanning in hospital settings—will need to support 10-, 11-, and 12-digit formats simultaneously during the transition period. For pharmacists, that means looping in wholesalers, pharmacy benefit managers, and third-party vendors early to assess readiness.

Experts also warn that OTC products will be impacted alongside prescription drugs, potentially involving entirely separate systems and barcode scanners. This is a complexity that will rival or exceed the rollout of the Drug Supply Chain Security Act (DSCSA).

Key actions for pharmacy leadership include auditing all systems that utilize NDC codes, engaging with trade groups like NCPDP and NACDS, and pressing for additional FDA guidance on phased implementation timelines.

The bottom line is that 7 years may sound like plenty of time, but history suggests the industry cannot afford to wait.

Stay tuned for weekly podcast episodes of Over the Counter powered by Drug Topics. Check out our most recent episode with Rick Gates, who discussed his organization’s newly introduced hybrid pharmacist role and how it is encouraging innovation in the retail pharmacy industry.

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