FDA Tweaks Drug Codes for Easier Barcode Scans
Published Date: 3/5/2026
Rule
Summary
The FDA is updating the National Drug Code (NDC) to a clear, 12-digit format with three parts to make drug labeling easier to read and track. They’re also allowing new types of barcodes on drug packages that meet these rules. This change affects drug makers and sellers and kicks in on March 7, 2033, giving everyone plenty of time to get ready without extra costs.
Analyzed Economic Effects
8 provisions identified: 6 benefits, 2 costs, 0 mixed.
All FDA NDCs Must Be 12 Digits
FDA requires every FDA-assigned National Drug Code (NDC) to be 12 digits in a 6-4-2 format (6-digit labeler, 4-digit product, 2-digit package). This requirement takes effect March 7, 2033 and applies to existing 10-digit NDCs, which must be converted to the 12-digit format.
Industry Cost Estimate Provided
FDA estimates annualized industry costs to convert to the uniform 12-digit NDC format at about $14.64 million (range $7.64M to $22.79M) using a 7% discount rate, and about $14.90 million (range $7.79M to $23.18M) using a 3% discount rate, over a 10-year horizon.
Standardization Aims to Reduce Medication Errors
FDA says a single, uniform 12-digit NDC format should reduce errors from converting between multiple NDC formats and lower the need for extra quality control by payors and prescribers. FDA also notes the rule should help avoid potential public-health risks from medication confusion.
7-Year Delay Before Rule Starts
FDA set the rule's effective date 7 years after publication, so the 12-digit NDC requirement starts on March 7, 2033. FDA states it will use that 7-year period to engage with and help industries prepare for the change.
3-Year Post-Effective Label Transition
After the March 7, 2033 effective date, FDA allows a 3-year transition period during which it does not intend to object to continued use of pre-existing 10-digit NDCs on drug labeling for products remaining in interstate commerce. During this transition, firms should make systems that can handle both 10-digit and 12-digit formats.
Barcode Options Expanded for Labels
FDA will allow either linear or nonlinear barcodes on drug labels as long as the barcode format conforms to the rule's standards and is recognized by FDA. This gives manufacturers flexibility in choosing barcodes that meet the new requirements.
FDA Will Publish 10-to-12 Digit Mapping
FDA intends to publish a database that maps each existing 10-digit NDC to its corresponding 12-digit NDC and will keep that mapping available at least until the end of the transition period. This mapping aims to reduce conversion errors during implementation.
Converted NDCs Aren't 'New' NDCs
FDA states converting a pre-effective-date 10-digit NDC into the 12-digit format is a ministerial administrative change and is not considered assignment of a "new" NDC for registration, listing, or user-fee purposes. A drug gets a truly new NDC only if FDA assigns a new NDC after the effective date because of a product change described in regulation.
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