NDC12 Implementation Timeline

    Key NDC12 milestones and deadlines

    Key milestones and compliance deadlines for the NDC12 transition

    Completed
    November 2018

    FDA Public Hearing: Future Format of the NDC

    The FDA held a public hearing on November 5, 2018, regarding the future format of the National Drug Code (NDC)

    Public Hearing Summary
    Completed
    July 2022

    FDA Proposed NDC12 Rule Published

    Food and Drug Administration's (FDA) proposed amendment regarding the format of the National Drug Code (NDC).

    FDA Proposed Rule
    Completed
    December 2022

    FDA Impact Analysis of NDC12

    Mandatory FDA report to assess the "...anticipated costs and benefits (of NDC12)... that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more..."

    Read more about FDA Impact Analysis of NDC12
    Completed
    March 5, 2026

    FDA Final Ruling on NDC12

    FDA’s final rule regarding the 12-digit format for the national drug code (NDC12). The rule outlines a "...seven-year period before the rule takes effect

    Final Rule
    In Progress
    March 7, 2033

    7-Year System Transition

    The March 2026 FDA Final Rule gives the industry seven years to upgrade systems, data structures, and packaging processes to support the new 12-digit National Drug Code (NDC12). This transition period ends in March 2033

    Upcoming
    March 7, 2036

    3-Year Labeling Transition

    The FDA Final Rule gives the industry three years to exhaust all remaining NDC10-coded products in the supply chain.