The New National Drug Code (NDC) Format

What is a Labeler Code or NDC Number ?

The NDC Number is a unique identifier used by FDA to identify the drugs marketed in the United States. Currently, the NDC Code is a 10-digit number with three segments in the format 5-4-1 or 5-3-2. FDA is proposing a new uniform format for all drug listings, new and existing; as per the new proposed guidance, all NDCs must be 12 digits in the format 6-4-2.

FDA will continue the same 3-segment format in the new requirement, Labeler Code- Product Code-Package Code. However, the length will be different; the first segment will be six digits, the second segment will be four digits, and the third will be two digits.

NDC Number Transition to the new format

In the proposed rule, the FDA allows a 3-year transition period following the final rule's effective date. During this proposed 3-year transition period, firms that use 10-digit NDCs must begin updating their labeling to replace the 10-digit NDCs with the new 12-digit NDC.

How to update 10-digit NDCs to become 12-digit NDCs?

Current listings with 10-digit NDC numbers can be changed to 12-digit NDC numbers by adding leading zeros to the labeler code, product code, and package code segments as required; the below illustration shows how to add leading zeros.

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