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# FDA Overhauls National Drug Codes
- URL: https://www.fdaweb.com/fda-overhauls-national-drug-codes/
- Published: 2026-03-04T12:00:00.000Z
- Updated: 2026-09-14T13:34:51.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5160762

FDA has finalized a sweeping overhaul of the National Drug Code system, adopting a standardized 12-digit format for the identifier used to uniquely distinguish prescription and over-the-counter drugs marketed in the U.S. Under a new [final rule](https://www.federalregister.gov/public-inspection/2026-04368/revising-the-national-drug-code-format-and-drug-label-barcode-requirements?ref=fdaweb.com), the agency will replace the current 10-digit National Drug Code (NDC) — which appears in multiple configurations — with a uniform 12-digit format. The change takes effect 3/7/2033.

On that date, FDA will begin assigning only 12-digit NDCs and will automatically convert all previously issued 10-digit codes to the new format. The update applies to FDA-assigned NDCs for human drugs, including biological products, as well as animal drugs. The rule does not alter non-FDA NDC standards used for other purposes, such as the 11-digit format commonly used in HIPAA-related reimbursement transactions.

Between now and 3/6/2033, FDA will continue issuing 10-digit NDCs under the current system. The seven-year lead time is intended to allow manufacturers, distributors, repackagers, relabelers, pharmacies, health care providers, payors and supply chain partners to update information technology systems, databases and operational processes to accommodate the 12-digit structure.

The agency also said companies should use the transition window to revise product labeling so that packaging reflects the new 12-digit NDC format by the effective date.

Under the rule,FDA also established a three-year labeling transition period from 3/7/2033, through 3/6/2036, to permit firms to phase in updated packaging and exhaust existing inventory bearing 10-digit NDCs. During that period, the agency does not intend to object to continued use of 10-digit codes on drug labels.

The rule also addresses barcode standards tied to the Drug Supply Chain Security Act (DSCSA). Beginning 3/7/2033, a single two-dimensional data matrix barcode may be used to meet both NDC labeling requirements and DSCSA product identifier requirements, provided it conforms to FDA-recognized standards developed by an international standards body such as GS1.

For DSCSA compliance, the 2D barcode may encode the 12-digit NDC using GS1’s application identifier 715, along with required product identifier elements including the serial number, lot number and expiration date.

FDA said both linear and nonlinear barcode formats will be acceptable if they meet recognized technical standards.

The agency will automatically update its drug listing files to reflect the new 12-digit NDC format on 3/7/2033\. Registrants will not be required to submit revised drug listing files solely to implement the format conversion. However, companies are expected to update listings once product labeling has been revised to incorporate the 12-digit NDC, the agency says.

FDA officials are urging affected stakeholders — including industry, payors and government agencies — to begin preparations well ahead of the 2033 deadline to ensure systems can process both 10-digit and 12-digit formats during the three-year overlap period.