The US Food and Drug Administration (FDA) has confirmed that the National Drug Code (NDC) system will shift to a uniform 12-digit format, replacing the current 10-digit structure used to identify medicines in the United States.
The change is intended to standardise drug identification across the pharmaceutical supply chain and ensure the system can support future growth in the number of approved products.
Under the new rule, all FDA-assigned NDC numbers for human and animal medicines will be converted to the 12-digit structure on 7 March 2033, with a transition period for labelling changes extending until March 2036.
Pharmaceutical manufacturers, distributors, healthcare providers and other supply-chain partners are expected to update systems and product labels ahead of the deadline.
Why the FDA is changing the national drug code
The National Drug Code is the FDA’s unique identifier for medicines marketed in the United States. It links each product to a specific manufacturer, formulation and package configuration and is widely used in prescribing, dispensing, reimbursement and supply-chain systems.
For decades, NDC numbers have consisted of 10 digits divided into three segments. However, the segment lengths have varied between formats such as 4-4-2, 5-3-2 and 5-4-1. This variation has created complexity when codes are used in electronic systems, billing transactions or barcodes.
The FDA has said a uniform format is needed partly because the existing system risks running out of available labeler codes, which identify manufacturers and distributors.
The new structure increases the available number combinations and aims to reduce inconsistencies in pharmaceutical data systems.
New 12-digit NDC structure explained
The revised 12-digit NDC format standardises the three code segments into a fixed structure:
- 6 digits for the labeler code, identifying the manufacturer or distributor
- 4 digits for the product code, specifying strength, dosage form and formulation
- 2 digits for the package code, describing package size and type
This consistent 6-4-2 configuration will replace the multiple formats currently used across the pharmaceutical sector.
When the rule takes effect, existing 10-digit NDC numbers will be converted automatically to the new format by adding leading zeros where required in each segment. Drug listing records will also be updated by the FDA to reflect the revised format.
Implementation timeline for pharma supply chains
The FDA has introduced a long transition period to allow organisations across the pharmaceutical supply chain to update databases, packaging systems and regulatory documentation.
From 5 March 2026 to 6 March 2033, the agency will continue assigning 10-digit codes while companies prepare for the new system. On 7 March 2033, all newly assigned NDCs will follow the 12-digit structure and existing codes will be converted in official records.
A further three-year transition period, running until 6 March 2036, will allow companies to update product labels and use up existing packaging that still displays 10-digit codes.
After this point, medicines introduced into interstate commerce with the older format may face regulatory action.
The FDA has advised manufacturers, pharmacies, distributors, payers and healthcare providers to begin updating IT systems and operational processes well before the deadline so they can manage both code formats during the transition.
The shift to a 12-digit National Drug Code format marks one of the most significant changes to US drug identification standards in decades.
For pharmaceutical companies and healthcare organisations, the update will require extensive data and labelling adjustments, but regulators expect the uniform structure to simplify drug identification, improve system compatibility and support long-term growth in the medicines market.
