US FDA has finalized a rule to follow a uniform 12-digit format for NDC instead of current 10-digit format. This change is happening because FDA is running out of 5-digit labeler codes and will soon need to issue 6-digit codes to accommodate new manufacturers.
As per new standard NDC numbers will be in strict 6-4-2 structure, totaling twelve digits:
- Labeler Code: six digits (identifies the manufacturer or distributor).
- Product Code: four digits (identifies the specific strength, dosage form, and formulation).
- Package Code: two digits (identifies package size and type).
Existing 10-digit NDCs will change to this new format by adding leading zeros to the short segments as needed. For example, a 5-3-2 format code like 12345-678-90 will become 012345-0678-90.
The transition is planned with a long lead time to allow the healthcare industry to update their IT systems, insurances, databases, and labeling processes.
Below is the timeline for New NDC format implementation
| Final Rule Published | March 5, 2026 |
| Effective Date | March 7, 2033 |
| Transition Period | March 7, 2033 – March 6, 2036 |
| Full Enforcement | After March 7, 2036 |
FDA is giving 3-year transition period starting from March 7, 2033, through March 6, 2036, for the manufacturers, distributors, pharmacies, health care providers, and other agencies to update their system to manage 12-digit NDC number.
As per new rule, both linear and nonlinear barcodes may be used to meet recognized standards like GS1. This allows a single 2D data matrix barcode to satisfy both NDC requirements and Drug Supply Chain Security Act (DSCSA) identifier rules.
FDA will automatically update all drug listing SPL files to show 12-digit NDC format on the effective date. Drug manufacturers will not need to resubmit or update their listings for the new NDC format. Drug manufacturers are expected to their drug listings and labeling to reflect new NDC format.
FDA has exempted certain biologics like certain specified human cells, tissues, and cellular and tissue-based products to continue to use an FDA- approved alternative format.
Liberty Management Group Ltd, provides assistance with drugs establishment registration, NDC labeler code request, Drug listings and US agent service to foreign facilities.
Sudha S
Regulatory Consultant
Email : office@libertymanagement.us