What is NDC Number (National Drug Code) ?
NDC number is 10 digit numerical code assigned to drugs. First 5 digits of the NDC number come from the labeler code. Labeler code is assigned by the FDA to manufacturer , distributor or brand owner of the product. The first step for NDC number is to obtain the labeler code from FDA. Our company can assist you get the labeler code. In order get the labeler code you should provide the DUNS number, company name and address . You can get DUNS number free of charge, we can assist your company to get the DUNS number.
After you complete the below online form for labeler code , we shall prepare the labeler code application on behalf of your company and apply for the labeler code. It may take 10 working days to obtain the labeler code.
After receipt of the labeler code , we can help you to assign product code and pack code for all your products. NDC number can be assigned in 5 -4-1 or 5 -3-2 format, which means you can assign either 4 or 3 digit code product and 1 or 2 digit pack code.
Let say, your company has obtained 12345 as 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.
Fore more information on NDC number format , please visit the below link.
After assigning the NDC number, we shall assist you to submit the drug listing to FDA. Drug listing is mandatory requirement for drugs commercially distributed in the USA. Drug listing can be verified at the below link.