Get Ready: FDA Revised the National Drug Code and Drug Label Barcode

In March 2026, the U.S. Food and Drug Administration (FDA) finalized its rule to standardize the format of the National Drug Code (NDC). Under this rule, FDA will move from a 10-digit format to a uniform 12-digit NDC for human drugs, including biological products, and animal drugs. Additionally, FDA is revising the drug product barcode label requirements to permit the use of other data carriers that meet the standards of this final rule.

This unique code assigned by FDA to identify each drug marketed in the U.S. can currently be in several different formats. Under the revised format, the segments will remain, but the digits may increase.

• First segment: the labeler code will be 6 digits
• Second segment: the product code will be 4 digits
• Third segment: the package code will be 2 digits

To provide maximum flexibility on the type of barcode used on the label of a drug product, this final rule allows the use of either linear or nonlinear barcodes, so long as the barcode format conforms to certain standards and is recognized by FDA. See § 201.25 for bar code label requirements. Prescription and OTC drug products dispensed through hospitals are required to include a bar code on the label that encodes the NDC number.

Plan Now for 2033

This change will have a significant impact on all drug manufacturers, distributors, repackagers, relabelers, pharmacies, health care providers, payors, and other supply chain partners. The good news is that there is a seven-year period for your company and partners to update software systems, processes, and infrastructure capable of handling a 12-digit system before the effective date of March 7, 2033.

FDA suggests companies should begin updating their labeling as soon as possible by adding leading zeros to the labeler code, product code, and/or package code segments as needed.

AAHP also suggests working toward the following:

• Update all product labeling: primary and secondary packaging
• Update product tertiary labeling (shipping case labels)
• Change internal product databases for inventory
• Change ERP (Enterprise Resource Planning) database connecting data into a single system from your company’s various departments (e.g., finance, HR, manufacturing, and supply chain)
• Update product information profiles with retailers and third-party logistics warehousing locations
• Update internal quality control specifications if affected
• Update tools for annual FDA CARES Act product reporting
• Potentially update all drug listings with FDA, although the agency says some will be updated automatically

Why the Revision?

FDA’s transition to a uniform format for native NDCs is intended to facilitate the adoption of a single NDC format across the entire healthcare industry. This will eliminate the need to convert NDCs from one of the FDA-assigned formats to a different standardized format used by other sectors of the healthcare industry (e.g., healthcare providers and payors).

Eliminating the need to convert NDCs should reduce potential errors caused by converting the FDA-assigned NDC to a different NDC format used by other sectors of the healthcare industry. Standardization and adoption of a single format will also eliminate the need for additional quality control and validation by certain stakeholders, such as payors and prescribers, to ensure a drug product and its respective NDC are accurate; this is particularly important for insurance coverage and reimbursement claims. Another benefit of the rule will be to avoid any potential risks to public health from medication errors and confusion. We do not have enough information to quantify these potential benefits.

Transition Period and More Information

There will be a three-year transition period beginning March 7, 2033, through March 6, 2036, to allow time to complete label updates and deplete old labeling stock. During this transition period, FDA does not intend to object to continued use of 10-digit NDCs on drug labels. Drugs labeled with a 10-digit NDC that are introduced into interstate commerce on or after March 7, 2036, may be subject to regulatory action.

Full information on “Revising the National Drug Code Format and Drug Label Barcode Requirements; A Rule by FDA,” published on March 5, 2026, can be found here:
https://www.federalregister.gov/documents/2026/03/05/2026-04368/revising-the-national-drug-code-format-and-drug-label-barcode-requirements