New FDA rule standardizes the National Drug Code structure and will convert existing 10-digit identifiers to a uniform 12-digit format by 2033.
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,” adopting a uniform 12-digit format for the National Drug Code (NDC).
The NDC is the FDA’s standard system used to uniquely identify drug products marketed in the United States. Currently, NDCs assigned by the FDA are 10-digit identifiers that may appear in several different configurations depending on how the digits are segmented.
The new rule standardizes the format to 12 digits, a change intended to improve consistency across regulatory systems and expand the number of available identifiers as the pharmaceutical market continues to grow.
Transition to a Uniform 12-Digit National Drug Code Format
Under the final rule, the FDA will move to a standardized 12-digit NDC format structured as:
6-digit labeler code – 4-digit product code – 2-digit package code
This replaces the current 10-digit system, where the NDC may appear in several formats depending on how the digits are segmented.
The rule takes effect on March 7, 2033.
On that date:
- The FDA will begin assigning new 12-digit NDCs to drug products listed in its registration system
- All previously assigned 10-digit NDCs will be converted to the standardized 12-digit format
- The new structure will apply to human drugs, biological products, and animal drugs
The transition is intended to ensure a consistent identification system across regulatory databases, healthcare systems, and supply chain platforms.
Scope of the Rule
The new rule applies specifically to NDCs assigned by the FDA as part of the drug registration and listing process.
Importantly, the rule does not change NDC formats used for other purposes outside FDA regulatory systems.
For example, the widely used 11-digit NDC format used under HIPAA for reimbursement and billing transactions will remain unchanged.
This distinction is important for organizations that rely on NDC numbers across multiple systems, including healthcare billing, pharmaceutical distribution, and regulatory reporting.
How Drug Products Receive an NDC
Drug manufacturers and repackagers must submit product registration and listing information to the FDA through the Electronic Drug Registration and Listing System (eDRLS).
Each listed drug is assigned an NDC that identifies:
- The labeler (company responsible for the drug)
- The product (including formulation and strength)
- The package configuration
These identifiers are published in the National Drug Code Directory, which serves as a public reference database of drug products marketed in the United States.
Preparing for the 2033 Transition
Although the current 10-digit NDC structure remains in use today, the FDA has finalized plans to transition to a standardized 12-digit format in 2033.
The shift to a uniform format may require long-term planning for companies involved in the pharmaceutical supply chain.
Organizations may eventually need to evaluate how the new format will interact with:
- Product labeling and barcoding systems
- Internal product databases
- Regulatory documentation and reporting systems
- Supply chain and inventory management platforms
The extended implementation timeline gives industry stakeholders time to prepare for the transition and ensure compatibility across systems that rely on NDC identifiers.
The Role of the Electronic Drug Registration and Listing System (eDRLS)
The Electronic Drug Registration and Listing System (eDRLS) is the FDA platform used by companies to submit required registration and drug listing information electronically.
Manufacturers, repackagers, and distributors must use this system to:
- Register drug manufacturing establishments
- List drug products marketed in the United States
- Update product information when changes occur
- Submit labeling information and product identifiers
Information submitted through eDRLS feeds several FDA databases and regulatory resources, including the National Drug Code Directory and other public drug information systems used by healthcare providers and regulators.
Accurate submissions through eDRLS help ensure that drug products are properly identified and traceable throughout the U.S. healthcare system.
Compliance Considerations for Pharmaceutical Importers
Although the current 10-digit NDC structure remains widely used today, companies involved in importing, distributing, or managing pharmaceutical products should begin preparing for the eventual transition to the standardized 12-digit format.
Organizations should ensure that:
- Drug listings submitted through eDRLS remain accurate and up to date
- Internal systems that capture or transmit National Drug Code (NDC) data maintain correct formatting
- Product labeling and packaging reflect the registered NDC numbers
- Supply chain documentation consistently uses the correct NDC identifiers
Maintaining accurate drug listing information helps ensure regulatory compliance and reduces the risk of discrepancies across supply chain and regulatory reporting systems.
Why Accurate Drug Identification Matters
Drug identification systems like the National Drug Code play a critical role in maintaining transparency and traceability across the pharmaceutical supply chain.
Accurate product identification supports:
- Regulatory compliance with FDA drug registration requirements
- Efficient tracking of drug products across distribution channels
- Clear communication between manufacturers, distributors, and healthcare providers
- Reliable data across healthcare and regulatory systems
As the FDA continues to modernize regulatory systems and data infrastructure, maintaining accurate and consistent product identification will remain an important part of pharmaceutical compliance and supply chain operations.
Questions About Regulatory Changes?
Global trade regulations and compliance requirements continue to evolve, and staying informed is essential for importers and supply chain teams.
The Alba Wheels Up team closely monitors regulatory developments and works with clients to navigate complex customs, compliance, and supply chain requirements.
If you have questions about how regulatory changes may impact your imports or operations, our team is here to help.
Contact us to speak with an Alba compliance specialist:
https://albawheelsup.com/contact-us/
