Regulatory Open Forum

 View Only

  • 1.  NDC code assignment

    Posted 09-Mar-2018 16:23
    ​I was looking through the FDA website to try to find out how to get an NDC assigned to my drug product.  My company already has a labeler code.  Can someone provide me with direction? How long does it take to get an NDC assigned?

    Thanks in advance,
    Stacy

    ------------------------------
    Stacy Macdonald
    San Diego CA
    United States
    ------------------------------


  • 2.  RE: NDC code assignment

    Posted 10-Mar-2018 05:31
    Edited by Anelis Aurand-Araos 10-Mar-2018 05:32
    Hi Stacy, the NDC is a number you create starting with your labeled code.  The first 5 numbers are the labeler code, the next 3 may be your internal item number, and the last 2 represent the package size - or however your company chooses to ​codify formulas & packaging. You submit the NDC in your drug listing and you hear back rather quickly on whether it's been accepted. Hope that helps!


    ------------------------------
    Anelis Aurand-Araos RAC
    Quality and Regulatory Affairs Professional
    www.qandrstrategies.com

    ------------------------------

    Original Message


  • 3.  RE: NDC code assignment

    Posted 12-Mar-2018 07:58
    Use CDER Direct to build and submit your SPL file for the product:

    https://direct.fda.gov/


    Original Message


Related Content