NDC number is 10 digit number which is grouped in three sets.
NDC number has three components
Labeler code identifies the labeler or responsible owner of the drug. Labeler can be any company who performs operations such as manufacturing, packing or distributor of the products.
Second set of NDC number is product specific, so labeler has to assign three or four digit product code for each drug they manufacture or distribute. The product code should be unique for each product. Drug products with the same active having different strengths or formulation will be considered as different products.
Last set of NDC numbers corresponds to pack code, which should identify the pack size and pack type.
So, NDC number format is 10 number digit can be a set of 4-4-2, 5-3-2, or 5-4-1.
If a company manufactures Drug A having 25 mg and 50 mg strengths in two pack sizes of 50’s and 100’s count, then NDC number will be as follows.
Consider 12345 , as a 5 digit number as labeler code assigned by FDA to the labeler.
NDC for Drug A 25 mg of 50 counts:- 12345-678-10
NDC for Drug A 25 mg of 100 counts:- 12345-678-20
NDC for Drug A 50 mg of 50 counts:- 12345-876-10
NDC for Drug A 50 mg of 100 counts:-12345-876-10
NDC for Drug A 50 mg of 10 counts blister:- 12345-876-30
In the above example;
12345 is FDA assigned labeler code
678 is the product code for Drug A 25 mg
876 is the product code for Drug A 50 mg
Since there is change in the active ingredient composition product is changed.
10 is the pack code for 50 tablets in the container
20 is the pack code for 100 tablets in the container
30 is the pack code for 10 counts in blister
Alternatively, you can assign the 4 digit product code and 1 digit pack code. However, once you follow NDC numbering format the same format should be continued for all the future products.
FDAbasics provides complete assistance for obtaining the labeler code, assigning NDC number, and drug listing if you have any questions please write to us.
It will take about 10 working days to obtain the labeler code from the FDA. After obtaining the labeler code we can help companies to assign the NDC number and completed the drug listing process.
Please contact us for more information.