Regulatory Open Forum

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  • 1.  Drug Listing

    Posted 02-Feb-2018 16:32
    Dear Colleagues,

    How long after Drug Listing will the NDC codes appear on the FDA's NDC Directory? The directory states it is updated daily but my listing from 2 days ago has not appeared.

    Thank you.

    David Lucking

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    David Lucking
    FL
    United States
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  • 2.  RE: Drug Listing

    Posted 03-Feb-2018 07:55
    It takes few days usually. Wait till Monday/Tuesday if you submitted your listing on Thursday/Friday. If it doesn't appear then I would recommend to contact FDA helpdesk.

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    Mariia Johnson, RAC
    Princeton NJ
    United States
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  • 3.  RE: Drug Listing

    Posted 05-Feb-2018 09:11
    In my experience, the NDC will not be reflected until there are drug listings.

    If you've only filed the NDC <g class="gr_ gr_52 gr-alert gr_spell gr_disable_anim_appear ContextualSpelling" id="52" data-gr-id="52">relabeler</g> request, then you may not be in the database even though your NDC was assigned. If you've filed a drug listing with the assigned <g class="gr_ gr_160 gr-alert gr_spell gr_disable_anim_appear ContextualSpelling ins-del multiReplace" id="160" data-gr-id="160">relabeler</g> code, then you should populate in the database after a couple of days.

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    Marc Sanchez
    Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
    Washington, D.C.
    United States
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