NDC number can be assigned in 5 or 5 format, which means you can assign either a 4 or 3 digit code product and 1 or 2 digit pack code. You can choose any 3 or 4 digit number as product code and 1 or 2 digit code pack. However, product code should be unique for every product. Similarly, for the same product package code should be unique for each packing type or configuration. For more information on the NDC number format, please visit the below link. It will take about 15 business days to complete the NDC drug listing process.
If you have any questions about FDA registration and listing requirements, please contact us. Who is required to submit an NDC drug listing? Manufactures Repacker or Relaber Each domestic facility must list each such drug regardless of whether the drug enters interstate commerce. Private label distributor How FDAbasics assist you with drug listing?
Drug establishments are required to provide FDA with a current list of all drugs manufactured, prepared, propagated, compounded or processed for sale in the U.
A labeler may be a manufacturer, including a repackager or relabeler, or the entity named on the product label. The NDC Directory contains product listing data submitted for all finished drugs including prescription and over-the-counter drugs, approved and unapproved drugs and repackaged and relabeled drugs.
The NDC unfinished drugs database contains product listing data submitted for all unfinished drugs, including active pharmaceutical ingredients, drugs for further processing and bulk drug substances for compounding. FDA does not submit or alter registration or listing data. Accuracy of the listing data is the responsibility of the company submitting the information to FDA.
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