NDSee You in 2033: FDA’s 12‑Digit NDC Is Coming

Read the final rule here.

An NDC is the unique identifier for virtually all drugs manufactured or sold in the United States. The requirement for NDCs is intended to ensure that every drug has a clear, unique ID that supports safety checks, tracking and recalls, and insurance and pharmacy billing. The current NDC has three segments: the labeler code, the product code, and the package code. The labeler code is a unique four- or five-digit FDA-assigned number that identifies the listing registrant. The product code and package code are proposed by the listing registrant. Depending on the length of the labeler code, the NDC appears in one of three configurations: 4-4-2, 5-3-2, or 5-4-1. In the future, under this new final rule, NDCs will comprise of a six-digit labeler code, four-digit product code, and a two-digit package code. The rule takes effect on March 7, 2033, and the FDA has set a three‑year transition period that runs through March 7, 2036. In simple terms, this change will reach every corner of the drug supply and health care delivery network, and companies and health care systems need to be ready to print, scan, store, send, and receive 12‑digit NDCs by the 2033 effective date, or face cascading compliance violations, operational breakdowns, and waves of denied claims and payments.

What the Final Rule Does and When It Applies

The rule sets one clear NDC format for everyone: 12 digits split into three parts. The first part is a six‑digit labeler code that the FDA assigns. The second part is a four-digit product code proposed by the listing registrant to identify the drug’s strength, dosage form, and formulation, and the third part is a two-digit package code, also proposed by the listing registrant, to identify package size and type; the FDA assigns the NDC if the proposed codes are valid and unique. A limited, existing exception remains for certain human cells, tissues, and cellular and tissue‑based products that may use an alternatively formatted NDC. On the effective date in March 2033, the FDA will start assigning only 12‑digit NDCs. The FDA will also convert all existing 10‑digit NDCs in its own systems to the 12‑digit format by adding leading zeros where needed, so firms do not need to resubmit listings just to change the number of digits.

The three‑year transition is meant to avoid waste and shortages. During the transition, firms are expected to switch labels to the 12‑digit NDC as soon as they reasonably can, and no later than when existing label stock is depleted. The FDA does not plan to object if products that were already in interstate commerce on the effective date keep showing a 10‑digit NDC during the transition. After the transition ends in March 2036, any product introduced or delivered for introduction into interstate commerce must bear the 12‑digit format. Products labeled with a 10‑digit NDC and introduced before the 2033 effective date may remain on the market after 2036 if they have not expired. Products introduced into interstate commerce after the effective date that still bear a 10‑digit NDC on the label are subject to enforcement if they remain in commerce after the transition.

The rule also updates barcode requirements. Drug labels may use linear or nonlinear (for example, two‑dimensional) barcodes if they follow a standard from a widely recognized international standards group and the FDA’s Center Director recognizes that standard. This aligns drug labels with the scanning technology already common in pharmacies, hospitals, and the supply chain. 

Who Is Affected and Why This Matters

This change touches the full drug ecosystem. It directly affects manufacturers, repackagers, relabelers, and private label distributors because new NDCs will be 12 digits and labels must move to the new format during the transition. It also affects pharmacies, hospitals and health systems, wholesaler distributors, payors, pharmacy benefit managers (PBMs), electronic health record and e‑prescribing vendors, 340B stakeholders, and revenue‑cycle and claims platforms. These groups depend on NDCs for distribution, dispensing, inventory management, billing, reimbursement, utilization tracking, supply chain security, recalls, and safety checks. It should also be noted that the Centers for Medicare & Medicaid Services utilize labeler codes and NDCs to operationalize reimbursement and drug pricing under Medicare and Medicaid and will need to update its system to accommodate the new 12-digit NDC formats. For instance, the Medicaid Drug Programs system, which is utilized to administer the Medicaid Drug Rebate Program, will require updating. Likewise, the US Department of Veterans Affairs system related to administration of the Federal Supply Schedule prescription drug schedules will also need updating. 

The impact is significant because a single NDC format reduces errors and delays. Today, many systems convert the FDA’s “native” NDC into a different length just to submit claims or move data. Those conversions can create mismatches, rejected claims, and safety risks. A single, 12‑digit format removes most of that friction. The barcode update matters too. Allowing linear and non-linear formats supports secure product tracing across the supply chain and reliable bedside medication scanning.

What to Do Now 

The 2033 date sounds far away, but the runway is shorter than it looks because this shift touches IT, labeling, supply chain, pharmacy, and billing, and you also need time to test with vendors and trading partners. ArentFox Schiff can provide end‑to‑end legal support by interpreting the final rule and related FDA guidance, advising on drug listing and labeling updates to meet the 12‑digit NDC and barcode requirements, preparing and reviewing FDA submissions and correspondence, assessing and mitigating enforcement and reimbursement risk, updating NDC‑related terms in contracts and policies with payors, PBMs, wholesalers, and vendors (including 340B and chargeback frameworks), and coordinating regulatory engagement so you stay on track and ready before the deadline.