An NDC currently has three segments: a labeler code assigned by FDA, a product code, and a package code. It is a 10-digit number in one of three formats, while billing systems commonly use an 11-digit version, which is a frequent source of confusion. In March 2026, FDA published a final rule moving all NDCs to a single 12-digit format, effective March 7, 2033, with a transition period running to March 2036.

Why it matters for labeling

The NDC appears on the carton, the container label, the prescribing information, the barcode and the SPL file, and every one of them has to match. FDA will update NDCs in listing files automatically, but the labeling itself is the company's responsibility, so each document will need to move to the new format consistently.

Common mistakes

  • Using the 11-digit billing format on the label
  • Transposed digits or misplaced dashes
  • Carton, container, barcode and SPL showing different values
  • Updating some documents but not others during the 12-digit transition

Sources