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The FDA is transitioning the National Drug Code to a standardized 12‑digit format, with the final rule taking effect on March 7, 2033. While the timeline may seem distant, this change will impact far more than labeling alone.
In this short video, RCA explains what is changing, why the FDA is expanding the NDC format, and what drug manufacturers should start preparing for now. We cover how the new 6‑4‑2 structure affects labeling, quality systems, internal databases, and product documentation, as well as the uncertainty around leading zero placement and FDA‑driven updates to drug listings.
You will also learn how the updated rule creates an opportunity to streamline packaging through the use of a single 2D data matrix barcode that can meet both NDC and Drug Supply Chain Security Act requirements.
Early planning is key. Companies that begin assessing impact and aligning internal systems now will be better positioned to reduce risk, avoid rework, and maintain compliance as the transition approaches.
If you have questions about how the 12‑digit NDC update affects your organization, RCA is here to help.
