On Monday, July 25, the US Food and Drug Administration (FDA) announced an update to the National Drug Code (NDC), replacing the existing 10-digit format with a 12-digit format in anticipation of a looming exhaustion of these codes within the next ten to 15 years.
The NDC, is an FDA standard for uniquely identifying drug products marketed in the United States used to register and track pharmaceutical products through the supply chain. As of now, composed of 10 digits, which are organized in three segments: the labeler code, the product code, and the package code. Under the proposed revision, the labeler code will consist of six digits, the product code four digits, and the packaging code two digits.
According to FDA, the change aims at facilitating the adoption of a single NDC format by all stakeholders, eliminating the need for converting NDCs from one of the current FDA formats to different ones. This should also decrease potential errors caused by these conversions.
Additionally, “Standardization and adoption of a single format would also eliminate the need for additional quality control and validation by certain stakeholders, such as payors and prescribers, to ensure a drug product and its respective NDC are accurate.”
To ease the transition, FDA will not require industry to “resubmit all of their drug existing drug listing files to convert the NDCs from one of the discontinued 10-digit formats to the new, uniform, 12-digit, 6-4-2 format. Instead, FDA intends to convert existing NDCs on its own, on the effective date, by adding leading zeros to the appropriate segments.”
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