Author

Marco Theobold

Director of Medical Device and Drug Services

Author

FDA Proposes Rule on Revising the NDC Format and Drug Barcode Label Requirements

Jul 28, 2022

On July 22, 2022, the U.S. Food and Drug Administration (FDA) announced a proposed rule to revise the ten-digit format for national drug codes (NDCs) to a uniform 12-digit format. This rule, Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No. FDA-2021-N-1351), would change FDA’s regulations on foreign and domestic establishment registration and listing for drugs listed under section 510 of the Food, Drug, and Cosmetic Act and 21 CFR part 207, including biological products and animal drugs. 

FDA assigns NDCs to uniquely identify drugs marketed in the United States. NDCs have been configured in a 10-digit format since their inception, and FDA is close to exhausting combinations for the 10-digit NDCs. This proposed rule, if finalized, would help minimize the impact of the demise of the 10-digit codes by establishing a uniform format for NDCs consisting of 12 digits with three consistent segments. FDA is also proposing to revise the drug barcode label requirements.   

FDA proposes a gradual transition from the 10-digit NDC to a 12-digit NDC that includes a delay in the date the final rule becomes effective to give the industry time to adjust. By selecting a date in advance of the transition, FDA is attempting to mitigate any confusion that could arise when the current format is no longer viable.  

The proposed changes will have a significant impact throughout the healthcare system and drug supply chain. Keep reading to learn more about what FDA proposes for NDC codes.  

FDA’s Proposed Changes  

When the finalized rule goes into effect, 10-digit NDCs will be required to convert to 12-digit NDCs, according to FDA’s formatting regulations.  

The general current format would remain the same: labeler code – product code – package code. However, FDA is proposing a more consistent approach to the numbers included in the NDC. The labeler code, which is now 4 or 5 digits would be changed to 6 digits. The product code, which is now 3 or 4 digits, would be 4 digits. The package code, now 1 or 2 digits, would be 2 digits.  

The drug barcode label requirements would also change if the rule is finalized. Currently barcodes must be displayed in a linear format, in accordance with 21 CFR 201.25(c). FDA is proposing the allowance for either linear or nonlinear barcodes on labels, as long as they are otherwise compliant.  

What will Companies Need to do?  

Because drug listing files would need to use the 12-digit NDC on or after the final rule’s effective date, some companies that use NDCs would need to ensure that their systems can process the new NDC format by that date.  

Companies would also need to update product labels to display the 12-digit NDC format.  

FDA is proposing a delayed effective date to give the industry ample time to transition to the new format. If finalized, FDA proposes making the final rule effective five years after publication. On that date, FDA will start to assign 6-digit labeler codes. New or updated submissions will need to use the 6-4-2 configuration. 

NDCs for existing drug listing files will need to be converted to the new format by adding leading zeros to the labeler code, product code, and/or package code segments. The table below is an example of how NDCs are currently formatted.

In this example, the NDC, in a 5-4-1 format, is 12345-6789-0: 

 Labeler Code   Product Code  Package Code 
 12345 6789 0

The table below is an example of how this NDC would be converted to the proposed format by adding leading zeros to segments that are currently too short, resulting in the 6-4-2 configuration.

The new NDC is 012345-6789-00: 

 Labeler Code   Product Code  Package Code 
 012345 6789 00

Manufacturers and distributors would have 3 years to transition labels to the 12-digit NDC. Although FDA “does not intend to object to the continued use of 10-digit NDCs on the labeling of products that were assigned a 10-digit NDC prior to the effective date”, FDA encourages those responsible for drug labeling to update their labels to the 12-digit format as soon as possible following the effective date.

Get assistance with FDA compliance.

Registrar Corp’s Regulatory Specialists help companies comply with FDA requirements. 

For assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day: www.registrarcorp.com/livechat.

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Author


Marco Theobold

Director of Medical Device and Drug Services

A highly regarded expert in medical device and drug regulations by the U.S. Food & Drug Administration (FDA), Marco brings a unique perspective for medical device and drug companies seeking to distribute products in the United States. He proudly provides guidance on FDA regulations for pharmaceutical, medical device, and radiation emitting device (RED) companies.

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