What Is an NDC Number? FDAbasics.com – Drug Listing
What is an NDC Number (National Drug Code) and Drug Listing? NDC number format explained.
NDC number is a ten-digit numerical code assigned to drugs. The first five digits of the NDC come from the labeler code. The FDA assigns labeler code to the manufacturer, distributor, or private label distributor of the product. The first step for the NDC number is to obtain a labeler code from the FDA.
Who is required to submit an NDC drug listing?
- PRepacker or Relaber
- PEach domestic facility must list each such drug regardless of whether the drug enters interstate commerce.
- PPrivate label distributor
Private label distributor
How FDAbasics assist you with drug listing?
After you complete the online NDC drug listing form, we shall prepare the labeler code application on behalf of your company and submit it to the FDA. About ten business days are required to obtain a labeler code from the FDA.
After receipt of the labeler code, we shall help you assign an NDC code for your products.
NDC number format
NDC number can be assigned in 5 -4-1 or 5 -3-2 format, which means you can assign either a 4 or 3 digit code product and 1 or 2 digit pack code.
Let say your company has obtained 12345 as a labeler code.
NDC number for your product X can be assigned as below;
12345- labeler code | 678 – Product code |89 -Pack code
12345- labeler code | 6789 – Product code |1 -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.
After assigning an NDC number for your products, we shall assist you in submitting the drug listing to FDA.
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.