NDC Labeler Code Assignment
What is a Labeler Code or NDC Number ?
The NDC Labeler Code is a unique 3 segment 10 digit number which identifies the drug. FDA assigns the first segment of the labeler code which represents the establishment. The second and third segments of NDC Labeler code are assigned by the labeler. Below example explain how to assign a labeler code.
Example of NDC Labeler code assignment
Assume the labeler code 12345 - 101 - 50 is for 50 ml sunscreen tube with active ingredient Zinc Oxide 20% manufactured by XYZ Company.
In this illustration, the first segment of labeler code "12345" identifies the Manufacturer - XYZ Company, and second segment "101" identifies the Drug - Sunscreen with active ingredient Zinc Oxide 20%. The third segment "50" identifies the package type and size - 50 ml tube.Back to previous page
|FDA Registration, US Agent, Labeler code||USD 649 (Annually)|
|Drug listing||USD 399 / Drug|
|Label Review||USD 649 / Drug|