On March 5, 2026, the U.S. Food and Drug Administration (FDA) issued a final rule revising the format of the National Drug Code (NDC), moving from the variable 10-digit structure to a single, standardized 12-digit format. While the new rule does not take effect until March 7, 2033, its implications for packaging, labeling and product identification begin now.
Why The NDC is Changing
The NDC is the FDA’s unique identifier for drug products. It is a three-segment code that identifies the manufacturer, the product, and the package configuration, and appears on drug labels and packaging across the healthcare system. Since NDC connects physical packaging to prescribing, dispensing and reimbursement systems, even small changes to its structure will have system-wide effects.
Under the current system, FDA-assigned NDCs are 10 digits long and are issued in multiple segment configurations (such as 4-4-2 or 5-3-2). This lack of uniformity has created long-standing challenges, requiring additional data normalization across systems and increasing the potential for discrepancies between physical products and digital records.
At the same time, the existing numbering structure is approaching capacity. Certain segments of the 10-digit NDC are expected to run out of available numbers in the coming years. Without a structural change, this would pose a significant risk to consistent product identification and traceability.
The FDA’s final rule resolves both issues by establishing a uniform 12-digit NDC format with a 6-4-2 structure. This standardization expands the numbering capacity and improves consistency across systems that rely on the NDC, ensuring it can support future product growth while enabling more reliable data exchange.
Key Dates and Transition Timeline
The transition will take place over several years:
· March 5, 2026 – March 6, 2033: A seven-year preparation period during which FDA will continue assigning NDCs under the current 10-digit format, and industry should update systems, processes, and infrastructure to handle the 12‑digit format.
· March 7, 2033: The 12‑digit NDC format becomes effective. FDA will convert existing FDA‑assigned NDCs to the new format by adding leading zeros as needed.
· March 7, 2033 – March 6, 2036: A three‑year labeling transition period during which FDA does not intend to object to continued use of 10‑digit NDCs on product labeling, allowing time to update artwork and deplete existing packaging inventory.
Packaging and Labeling Implications
From a packaging perspective, the transition to a 12-digit NDC will require updates to product labels, packaging artwork and barcoding strategies. In some cases, existing packaging configurations may not easily accommodate the expanded identifier without redesign.
The finalized rule allows the use of two-dimensional (2D) barcodes to encode the NDC on product labeling, giving manufacturers more flexibility in how product information is represented. Linear barcodes have traditionally been used on non-prescription drugs to encode NDCs, but they are limited in how much data they can hold. As identifiers expand and additional data elements are incorporated, these constraints can create challenges, particularly on smaller packages.
2D barcodes, such as the GS1 DataMatrix, can encode significantly more information in a smaller space, making them a more practical option for carrying expanded product data.
Adoption of 2D barcodes is already underway in parts of the industry, as pharmaceutical manufacturers have implemented the DataMatrix to meet Drug Supply Chain Security Act (DSCSA) requirements for serialized prescription drugs. The use of 2D barcodes has helped enable the interoperable exchange of data, leading to a safer and more secure supply chain. These benefits and more can be similarly unlocked for over-the-counter (OTC) and animal health products.
Updating packaging will require coordination across labeling, regulatory, operations and IT departments. Packaging teams will need to evaluate label real estate, print quality, scanner performance and regulatory requirements. Even small changes can affect production, distribution and point-of-care scanning.
A supply Chain-wide Impact
While packaging is a critical touchpoint, the NDC update affects all systems that rely on product identification, from prescribing and pharmacy workflows to inventory management and reimbursement.
Manufacturers, distributors, pharmacies, solution providers and healthcare systems will need to update systems to recognize and process the new format. For a while, systems will need to consume both the 10- and 12-digit NDCs, as inventory already in the supply chain gets sold and used. If updates aren’t aligned, mismatches between product and associated data can lead to rejected shipments, delays in dispensing and reimbursement issues.
Using Data Standards to Reduce Complexity
Standards-based approaches can help reduce complexity across packaging and systems. GS1 Standards, such as GS1 Global Trade Item NumbersÒ (GTINsÒ) for product identification and Electronic Product Code Information Services (EPCIS) for data sharing, provide a common framework for aligning physical products with digital information across the supply chain. For pharmaceutical products, a GTIN can incorporate the current 10-digit NDC in a linear barcode, but not the new 12-digit version. As a result, the NDC will be encoded into an Application Identifier (AI) allowing for continued association to the GTIN. Since UPC-A barcodes cannot carry AIs, 2D barcodes will be necessary.
The GTIN bridges U.S. regulatory identification with global supply chain standards and enabling consistent use in barcodes and interoperable data exchange. This can help ensure that product information is captured and shared accurately from manufacturing through dispensing.
The Risk of Waiting
Although the U.S. FDA’s timeline provides several years for full implementation, waiting increases the risk of disruption, added cost and rushed implementation.
Packaging changes require time for design, validation, approval and rollout across multiple SKUs, while updating legacy systems and aligning data across partners can be complex. Companies that delay planning may find themselves managing packaging redesigns and system updates under tighter deadlines, increasing both cost and operational risk.
Planning for What Comes Next
The shift to a 12-digit NDC format underscores the need for proactive planning and cross-functional collaboration. As organizations evaluate the impact of the change, key questions will include how to update packaging efficiently, whether to adopt more advanced barcode technologies and how to ensure alignment across internal systems and external partners.
Companies that start early and align packaging, data and systems can avoid last-minute disruption and move through the transition more smoothly. Ultimately, the NDC update strengthens the foundation for a more consistent, traceable and connected healthcare supply chain.
The GS1 US Healthcare Initiative has a special workgroup to address NDC change recommendations and best practices for stakeholders across the industry. Participation in the workgroup is available to any GS! US Healthcare Initiative member. For more information about GS1 Standards in healthcare, please visit www.gs1us.org.
