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Revising the National Drug Code Format and Drug Label Barcode Requirements; Final Regulatory Impact Analysis

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to standardize the format of the National Drug Code (NDC). This final rule requires that all NDCs, including any 10-digit NDCs issued by FDA prior to the effective date, be 12 digits in length with a uniform format: a 6-digit labeler code, a 4-digit product code, and a 2-digit package code. As a result, drug product labeling that includes a 10-digit NDC will need to be updated to convert to the standard 12-digit format.

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. Such an adoption 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 the public health from medication errors and the risk of confusion. We do not have enough information to quantify these potential benefits.

The costs to industry of converting current NDCs to the standardized format will include one-time costs of updating software systems, other transition costs, coordinating labeling updates, and reading and understanding the rule. We estimate annualized costs will be about $14.64 million ranging from $7.64 million to $22.79 million using a 7-percent discount rate over a ten-year horizon. Similarly, we estimate annualized costs will be about $14.90 million ranging from $7.79 million to $23.18 million using a 3-percent discount rate over a 10-year horizon.

Regulatory Impact Analysis

 Revising the National Drug Code Format and Drug Label Barcode Requirements. Final Regulatory Impact Analysis (PDF- 493.06KB)

Federal Register: 91 FR 10749
Publication Date: March 5, 2026
Docket: FDA-2021-N-1351

 

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