The Challenge

FDA's final rule establishes a single, uniform 12-digit format for FDA-assigned National Drug Codes (NDCs) beginning in 2033. Today, NDC codes exist in multiple 10-digit, and sometimes 11-digit, configurations that organizations interpret differently across systems. Transitioning to 12 digits requires coordinated changes across every part of the healthcare system, spanning manufacturers and distributors to providers, payers, and regulators.

• Changes will span hundreds of systems and processes across every sector

• Organizations must operate in a mixed 10-, 11-, and 12-digit environment for years

• Critical dependencies exist across clinical, financial, supply chain, and regulatory functions

• Success depends on synchronized execution across independent actors

A cross-sector coordination body designed to ensure the entire ecosystem moves forward with shared insight, aligned priorities, and coordinated execution.