NDC Number - NDC Labeler Code
What is a Labeler Code or NDC Number ?
The labeler code is a 5 digit number assigned by the FDA, this is a unique number for each labeler. The labeler code represents the establishment or labeler.
The NDC Number (National Drug 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. The NDC Number for each drug will be different. 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.
How to get NDC Number?
In order to get the NDC Labeler code, the labeler need to prepare and submit an "NDC Labeler code request SPL" to FDA. FDA will not accept the submission in paper format or via e-mail. The labeler need to submit the SPL via ESG or CDER Direct Portal.
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NDC Number - Frequently Asked Questions
NDC number is a 10-digit number; FDA will assign the first five digits; This is the labeler code that identifies the labeler, and the labeler assigns the next five digits.
The FDA and other healthcare organizations primarily use NDC numbers for tracking and reporting purposes.
Yes, Homeopathic drugs marketed in the USA must be listed with an NDC number.
No, an NDC number is not required for dietary supplements; an NDC number is only for drugs.
No, there is no onsite FDA establishment inspection as part of the NDC number assignment.
No Labeler code is not location specific; you can request one labeler code for the company.
NDC Number Requirements
|FDA Registration, US Agent, Labeler code||USD 649 (Annually)|
|Drug listing||USD 399 / Drug|
|Label Review||USD 649 / Drug|