On March 5, 2026, the United States Food and Drug Administration (FDA) published the final rule on the National Drug Code Format (NDC) and Drug Barcode Label Requirements. According to this rule, the FDA will replace the current 10-digit NDC format with 12-digit codes, with the transition starting in 2033, and fully finalized on March 6, 2036.
The FDA will continue to assign 10-digit codes until 2033. However, the recommendation to all enterprises and organizations that handle National Drug Codes is to update their systems, processes, and infrastructure before the last phase of the transition begins in 2033.
“The seven-year period before the rule takes effect is also intended to provide companies with sufficient time to update their labeling to ensure that updated labeling with NDCs in the new 12-digit format are ready for use on the effective date.”
— Statement by the U.S. Food and Drug Administration
Organizations that don’t update their systems, processes, and infrastructure by March 6, 2036, risk facing non-compliance with the requirements related to the Drug Supply Chain Security Act (DSCSA), Controlled Substances Ordering Systems (CSOS), EDI business transactions, and product labeling. This may lead to operational disruptions and increased regulatory scrutiny. The FDA stated in 2026 that they will not allow any additional extensions or delays, so the March 7, 2036, date is the final hard deadline.
Key dates:
- March 5, 2026: FDA final rule published.
- March 5, 2026 – March 6, 2033: FDA continues assigning 10-digit NDCs; systems should be upgraded.
- March 7, 2033: FDA begins assigning 12-digit NDCs; existing 10-digit NDCs auto-convert; new 12-digit NDCs are to be placed on all new product labeling.
- March 7, 2033 – March 6, 2036: Three-year labeling transition for pre-labeled inventory; both formats may coexist on labels preceding the transition, while 10-digit codes are still allowed on pre-transition product packaging.
- March 7, 2036: Hard deadline; 10-digit labeled products are subject to regulatory enforcement action.
The 10-year timeframe might seem like a long time, but realistically, it is roughly two times shorter. The change in your operations should happen before the three-year final transition period to facilitate the labeling of new products. Assuming one year of testing before the final transition period, including planning and approving the budget for the testing beforehand, that leaves organizations a much shorter 5 years of lead time out of 10 in total. Axway works with many enterprises that handle National Drug Codes, and we keep a close eye on new regulations. While the adoption of the 12-digit format will benefit the industry, the migration to the new format of data may bring temporary troubles.
In this blog, I will explain the details of this transition and tell you how Axway can help approach this transition with confidence and a plan.
Making sense of National Drug Codes
The Drug Listing Act of 1972 requires “registered drug establishments” to provide the FDA with a list of manufactured, prepared, propagated, compounded, or processed drugs for commercial distribution. The FDA identifies all drugs with a unique, three-segment number, which is called the National Drug Code, or NDC. The three segments have dedicated purposes: the first segment is the digital code for labelers that manufacture or distribute the product, the second segment is the product code, and the third segment is the package code.
Over five decades later, the NDC added a digit, resulting in the current 10-digit codes, and the three-segment structure became less unified. Instead of having one constant format, the FDA and regulated organizations use three different formats for segmentation: 4-4-2, 5-3-2, and 5-4-1. That means that some labelers have 4-digit codes, some labelers have 5-digit codes. Some products have 3-digit codes, some products have 4-digit codes.
For any specialist or organization that works with data, this lack of unification can become a digital nightmare.
Moreover, the NDC is not an isolated code. For all organizations that participate in global pharmaceutical trade or global supply chains for medication, the current 10-digit NDC is also a part of GTIN, or Global Trade Identification Number. The 10-digit NDC is specifically a part of the 14-digit GTIN, but GTIN is also not limited to just 14 digits. Adding 2 digits to NDC will cause a discrepancy with the 14-digit GTIN: two additional digits of the new NDC won’t fit into the 14 digits of the current GTIN.
That means that adding just two digits to the NDC introduces several separate data management issues:
- Transition from 10-digit codes to 12-digit codes.
- Transition from 4-4-2, 5-3-2, or 5-4-1 to the new unified segmentation: 6-4-2.
- Maintaining a link between 12-digit codes and historic data.
If you are a part of an organization that must comply with the FDA regulations, the time to make these decisions has come.
What the FDA’s 12-digit NDC means for barcodes
The FDA’s move to a standardized 12-digit (NDC) will have a direct impact on how pharmaceutical products are labeled and scanned across the supply chain. Today’s barcodes often embed the existing 10-digit NDC in various formats, but the transition to a fixed 12-digit structure will require updates to barcode data encoding, labeling systems, and scanning software and hardware.
For manufacturers, this means redesigning product packaging to ensure barcodes accurately reflect the new 12-digit format while remaining compliant with GS1 standards and other regulatory requirements. Distributors, pharmacies, and healthcare providers will also need to confirm that their scanning systems can read and process the updated codes without disruption.
Importantly, this is not just a packaging change. Barcode updates must be coordinated across trading partners and validated through testing to ensure interoperability. Organizations that start early will be better positioned to make these changes smoothly, avoid relabeling delays, and maintain seamless product identification throughout the supply chain.
Assessing the impact of the NDC transition on software and hardware
The FDA will handle the transition for existing codes automatically by adding zeros to complete the three segmentation formats to one unified 6-4-2 standard. Depending on your current NDC segmentation format, this is how the change will look for you:
- For 4-4-2 formats, add two leading zeros at the beginning of the first segment (labeler code) to convert the first 4 into a 6.
- For 5-3-2 formats, add one leading zero at the beginning of the first segment (labeler code) to convert the 5 into a 6, and one leading zero at the beginning of the second segment (product code) to convert the 3 into a 4.
- For 5-4-1 formats, add one leading zero at the beginning of the first segment (labeler code) to convert the 5 into a 6, and one leading zero at the beginning of the third segment (package code) to convert the 1 into a 2.
These changes may seem trivial, but they will require significant updates to labeling, product serialization systems, data management, and barcodes. Although the FDA will automatically add necessary digits, you are still responsible for preparing your software and hardware systems for this change.
- For manufacturers, the change will affect the management of supply chains and labeling.
- For organizations dealing with pharmaceutical products, your inventory and prescription management systems need to start accepting new 12-digit NDCs.
- For organizations dealing with physical barcodes, evaluate barcode scanning equipment to ensure existing scanners can reliably read and process the updated labeling and barcode formats introduced in the transition.
- For insurance organizations, 12-digit NDCs will be required for claims management systems and reimbursement workflows.
- For all of the above, the transition will change your interactions with regulators and external partners.
As you start transitioning the numerical values in your software, the best practice is to keep a link between your old 10-digit codes and the new 12-digit NDC. This will be most relevant during the final transition period from 2033 to 2036, when the new 6-4-2 standard will be implemented. Ensuring a link between old codes and new codes will help you keep continuity of systems and inventory.
For your B2B integration systems, the key issue is mapping. The best first step is to make an exhaustive inventory of your software systems that deal with National Drug Codes before conceptualizing the transition of your systems from 10-digit to 12-digit NDC, and to standardize how NDC formats and hyphenation of codes are represented in your databases and integrations.
How Axway helps with the 12-digit NDC transition
Axway has been helping pharmaceutical and healthcare organizations comply with regulatory mandates like uniformity of digital data for over a decade. Axway B2B integration products like Axway Track & Trace and Axway Controlled Substances Ordering System (CSOS) help pharmaceutical supply chain participants meet regulatory mandates around the world. We work directly with regulatory bodies, administrative agencies, and industry groups to meet today’s pressing traceability challenges.
Axway is here to help with the 12-digit NDC transition. We follow regulations in detail via our cooperation with government agencies and industry groups, and notify our users ahead of time to help them prepare for the transition. Axway’s Professional Services Organization (Axway PSO) accommodates the transition by compiling the software inventory, evaluating the general health of systems, estimating the impact of the transition, creating an action plan, and assisting with the migration and continuity of systems. We also include regression testing across EDI transactions, APIs, barcode systems, and partner integrations to be completed before the 2033 transition window begins.
See also: Cencora’s decade of EDI success with Axway B2Bi
However, if you run a legacy system, it may not be able to support this kind of transition. Legacy applications that assume a fixed 10-digit field length may fail unexpectedly once 12-digit values start appearing in transactions, integrations, and workflows. Axway B2Bi supports traditional EDI and complements it with modern technologies of API and artificial intelligence. If your B2B integration software doesn’t support the transition from 10-digit codes to the new 12-digit NDC, our experts can assist you in migrating to modern EDI/API support first and then help transition to 12-digit NDC with extensive testing.
While the NDC 12-digit transition is often described as a 10-year industry effort, the effective timeline for most organizations is materially shorter. With only about seven years until compliance deadlines and at least one year required for end-to-end testing, validation, and partner coordination, the true window for design and implementation is closer to five to six years. This compressed timeline underscores the need for early planning and proactive investment to avoid last-minute risk and disruption.
You don’t have to be alone in this process. Axway’s experts are ready to help.