USFDA Revised Rule: National Drug Code Format and Drug Label Barcode Requirements
- Sharan Murugan
- 5 hours ago
- 3 min read
The U.S. Food and Drug Administration (FDA) has issued a final rule titled “Revising the National Drug Code Format and Drug Label Barcode Requirements.” This rule introduces a uniform 12-digit National Drug Code (NDC) format to standardize how drugs marketed in the United States are identified.
The National Drug Code is an FDA standard used to uniquely identify drug products marketed in the U.S. Currently, the NDC assigned by FDA is a 10-digit number, and it may appear in different configurations depending on how the segments are structured.
Under the final rule, the NDC format will be standardized to 12 digits to improve consistency, efficiency, and compatibility across regulatory and healthcare systems.
Overview of NDC
The National Drug Code is a three-segment numerical identifier assigned to drugs listed with the FDA. Each segment of the code represents specific information about the drug product, including the manufacturer or distributor, the product itself, and the packaging configuration.
Structure of the National Drug Code
The National Drug Code consists of three segments that together identify the labeler, the product, and the package.
Labeler Code : The first segment of the NDC identifies the labeler. The labeler is the company responsible for manufacturing, repackaging, or distributing the drug product. The FDA assigns the labeler code when a firm registers with the agency as part of the drug establishment registration process. This code uniquely identifies the company associated with the drug product.
Product Code: The second segment identifies the specific drug product & provides information about characteristics of the drug product, such as:
Strength
Dosage form
Formulation
Each distinct product marketed by a labeler receives a unique product code.
Package Code: The third segment identifies the packaging configuration of the drug product. This code distinguishes between different package sizes and types for the same product. For example, the same drug may be marketed in multiple package sizes, and each packaging configuration receives a unique package code.
However, the number of digits in each segment can vary.
The common configurations include:
4-4-2 format
5-3-2 format
5-4-1 format
Effective Date of the New NDC Format: The new rule will take effect on March 7, 2033. The FDA has provided a seven-year preparation period from March 5, 2026 through March 6, 2033.
Beginning on this date:
FDA will assign new 12-digit NDCs for drug products.
All previously assigned 10-digit NDCs will be converted to the uniform 12-digit format.
This change will apply to FDA-assigned NDCs for human drugs, biological products, and animal drugs.
However, the rule does not change NDC formats used for other purposes outside FDA, such as the HIPAA standard 11-digit format used for reimbursement systems.
During this period:
FDA will continue assigning 10-digit NDCs.
Manufacturers, distributors, pharmacies, healthcare providers, payors, and other supply chain partners should update systems and infrastructure to support the new 12-digit format.
Companies are also expected to begin preparing updated drug labeling so that products are ready for the new format by the effective date.
FDA has established a three-year transition period from March 7, 2033 to March 6, 2036 to allow companies to update product labeling and use existing label stock.
During this transition:
FDA does not intend to object to continued use of 10-digit NDCs on labels.
Companies should gradually update labels to display the 12-digit NDC by adding leading zeros where necessary.
After March 7, 2036, drug products introduced into interstate commerce with a 10-digit NDC may be subject to regulatory action.
DSCSA and Barcode Requirements
The rule also addresses barcode requirements associated with the NDC.
Linear or nonlinear barcodes may be used if they follow FDA-recognized standards such as those developed by GS1.
For Drug Supply Chain Security Act (DSCSA) requirements, a 2D data matrix barcode can encode the 12-digit NDC along with the product’s serial number, lot number, and expiration date.
Starting March 7, 2033, a single 2D barcode may meet both NDC labeling requirements and DSCSA product identifier requirements.
Drug Listing Updates
On March 7, 2033, FDA will automatically update drug listing records to reflect the 12-digit NDC format.
Registrants will not need to submit new listing files solely for the format conversion, but they should update listing information once product labeling is updated to include the new NDC.
Reference
For more details on this regulatory update, please refer to the official FDA webpage through the link below.
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