On March 5, 2026, FDA published a final rule titled Revising the National Drug Code Format and Drug Label Barcode Requirements (91 FR 10749, RIN 0910-AI52). The rule ends the current situation in which a National Drug Code can be ten digits long in five different configurations. Once the rule takes effect, every NDC assigned by FDA will be twelve digits in one uniform format. For drug labelers, including foreign manufacturers that list drugs for the US market, the change is administrative rather than a new approval step, but it touches labels, barcodes, listing data, ordering systems and every database that stores an NDC.
Key dates: effective March 7, 2033, then a three-year transition
The rule is effective on March 7, 2033, seven years after publication, and it is followed by a three-year transition period. FDA will continue to assign ten-digit NDCs until the effective date, and it has said that affected parties should not expect or anticipate extensions. FDA also intends to publish a database that maps each ten-digit NDC to its twelve-digit equivalent, at least until the transition period ends.
During the transition, FDA does not intend to take action against unexpired product labeled with a ten-digit NDC that was introduced into interstate commerce before the effective date. Product introduced with a ten-digit NDC after the effective date and before the end of the transition is treated differently: it is subject to enforcement if it remains in commerce after the transition period ends.
The new format: one 6-4-2 structure
Today an NDC is ten digits split into a labeler code, a product code and a package code, in one of five configurations: 4-4-2, 5-3-2, 5-4-1, 6-3-2 or 6-4-1. Under the amended 21 CFR 207.33(b), all FDA-assigned NDCs will be twelve digits in a single 6-4-2 format: a six-digit labeler code, a four-digit product code and a two-digit package code. New six-digit labeler codes will not begin with zero, so the first new code is 100000. FDA emphasizes that leading zeros are part of the NDC and must not be truncated.
Existing NDCs are converted, not reassigned
Current ten-digit NDCs are converted by adding leading zeros to the labeler, product and/or package segment as needed to reach the 6-4-2 structure. A five-digit labeler code, for example, gains one leading zero, and a three-digit product code gains one leading zero. FDA describes this conversion as a ministerial, administrative change rather than the assignment of a new NDC, so converting a ten-digit NDC to its twelve-digit form is not treated as a new NDC for drug registration, listing or user-fee purposes. Because converted labeler codes begin with zero and new labeler codes do not, the two remain distinct.
Barcodes: UPC-A cannot carry a twelve-digit NDC
The rule also revises the drug label barcode requirement in 21 CFR 201.25(c). Labels may use a linear or nonlinear barcode that conforms to standards from a widely recognized international standards development organization and is recognized by the relevant FDA center. FDA notes that the UPC-A barcode cannot encode a twelve-digit NDC, while the GS1 Application Identifier (715) can encode it in GS1-128, GS1 DataBar or GS1 DataMatrix symbols, which are read by camera-based scanners. A single 2D barcode may meet both this rule and the Drug Supply Chain Security Act product identifier requirements, and linear and nonlinear barcodes may appear on the same label when each applicable requirement is met.
What the rule does not change
The rule does not change the 11-digit NDC used under the HIPAA transaction standards; FDA states that HIPAA code sets are outside its authority, although it expects that standard to be updated. Messages that the FD&C Act requires to include an NDC must use the twelve-digit format after the transition period ends. The rule applies to human drugs, biological products and animal drugs. FDA declined to treat allergenic products differently and kept the existing alternative format provision for human cells, tissues and cellular and tissue-based products.
How foreign labelers should prepare
- Inventory every NDC you own, down to package level, and record its twelve-digit equivalent once FDA's mapping database is available.
- Check every system that stores or validates NDCs, including ERP, artwork, serialization and data exchange with US customers, for fixed ten-digit assumptions.
- Plan label and barcode changes, especially where a UPC-A symbol currently carries the NDC.
- Coordinate with US importers, distributors and contract packagers, because the same NDCs appear in their systems and documents.
- Keep listings current in the meantime: the format change does not replace the June and December listing updates or the annual no-changes certification.
Until the effective date, new labeler codes and NDCs are still issued in the ten-digit format. Obtaining a labeler code now does not create duplicate work later, because existing codes convert administratively. Today's ten-digit structure is explained in what an NDC number is and how foreign drug manufacturers obtain one, and the year-end listing obligations are covered in the drug establishment renewal and blanket no-changes certification guide.
How FDABridge helps
FDABridge applies to FDA for NDC labeler codes on behalf of foreign drug companies and prepares drug listings as per-product SPL submissions. Service scope is described on the NDC Labeler Code service page and the drug listing service page, and the full set of drug services is on the drug services page.
Source: Federal Register, Revising the National Drug Code Format and Drug Label Barcode Requirements, 91 FR 10749 (March 5, 2026): https://www.govinfo.gov/content/pkg/FR-2026-03-05/html/2026-04368.htm