6-4-2 Blastoff! FDA’s New NDC Format Coming … in 2033 March 11, 2026 By Kalie E. Richardson & Karla L. Palmer & Dara Katcher Levy —

https://www.thefdalawblog.com/2026/03/6-4-2-blastoff-fdas-new-ndc-format-coming-in-2033/?utm_source=rss&utm_medium=rss&utm_campaign=6-4-2-blastoff-fdas-new-ndc-format-coming-in-2033 FDA has published its long awaited Final Rule Revising the Nation and Drug Code Format and Drug Label Barcode Requirements which will expand the dwindling supply of FDA labeler codes and corresponding NDCs to what FDA states is a 900-year supply. As a reminder, NDCs are broken into three segments: labeler code, product code, and package code. The three-part structure of the NDC is not changing under the Final Rule, and is identical to the format in the 2022 Proposed Rule. NDCs currently in use are 10-digits long, and are configured as follows: 4-4-2; 5-3-2; 5-4-1. Prior to this final rule, the current version of the regulations allows for FDA to begin assigning 6 digit labeler codes once 5 digit labeler codes have been exhausted, while still allowing variability in the length of product and package code segments, resulting in five potential NDC formats of 10 or 11 digits: 4-4-2; 5-3-2; 5-4-1; 6-3-2; and 6-4-1. As raised by several commenters, the formatting variations have long been a recipe for confusion. For example, if an 11-digit NDC were transmitted without the hyphens, a 5-4-1, 6-3-2, and 6-4-1 NDC format would all be indistinguishable, which raises the risk of data loss and product mix-up. All stakeholders agree that a single format is preferable and the Final Rule eliminates the formatting variations as summarized in the table below: