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Regulatory Focus™ > News Articles > 11 > FDA Begins Preparations for New NDC Coding System

FDA Begins Preparations for New NDC Coding System

Posted 05 November 2018 | By Zachary Brennan 

FDA Begins Preparations for New NDC Coding System

With the US Food and Drug Administration (FDA) running out of National Drug Code (NDC) numbers in the next decade or so, a public meeting on Monday discussed multiple options for how to amend a code that affects just about every part of the US health care system.

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, kicked off the meeting noting how ubiquitously NDCs are used – from e-prescribing to adverse event reporting to track and trace to reimbursement.

So why is FDA beginning this transition process so early? Woodcock made clear that in order for all of these health systems to transition to a new system, “it takes years and years once the standard is in place to change the systems.”

The economic difficulties of making such a major change also will have to be ironed out, particularly as labeling and packaging may need to change with a new system, she added.

“You can’t just flip a switch and implement the changes overnight,” Woodcock said.

Monday’s meeting featured presentations from a variety of stakeholders discussing what a change to a new format would mean, with many offering conflicting and different views on where the agency should go.


The NDC is a statutorily created FDA standard for uniquely identifying drugs in the US, and FDA anticipates it will run out of the 5-digit labeler codes in approximately 15 years.

The NDC is a 10-digit number with three segments to identify the company, the product and the package size and type, via the labeler code, the product code and the package code.

The 11-digit NDC, a derivation of the FDA’s official 10-digit NDC, is required by HIPAA for electronic records transactions, in addition to being used by health payers, such as Medicare. For more on the changes and expectations for what’s coming, here are slides presented by FDA:




In comments at the meeting, an Apotex representative noted that from a manufacturer’s perspective, NDCs are maintained in a GTIN-12 format as a string of digits with no separation. He noted data integrity and maintenance issues if there are additional formats used.

In terms of barcoding, the NDC-10s are embedded in a GTIN-14 for serialization and barcoding purposes.

Rather than use one of FDA’s four proposals, Apotex offered its own proposal, addressing the labeler code and the product identifier/pack size.

Embedding the NDC into the GTIN-14 “is a high priority for future use,” the Apotex representative said. He also called to move to a 7-digit labeler code to match the GS1 company prefix.

A Walgreens representative called for FDA to make whatever changes it does after 2023, when Drug Supply Chain and Security Act requirements are also coming. 

Public Hearing: Future Format of the National Drug Code

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