The National Drug Code is a unique 10-digit 3-segment number assigned to each drug product listed with FDA. This number is known as NDC Number. The first 5 digits (first segment) identify the labeler or Drug Manufacturer. This is assigned by the Food and Drug Administration (FDA) upon submission of a Labeler Code Request.
The second segment (next 3 digits) identifies the Drug, and the third segment (last 2 digits) is the package code, which identifies package sizes and types. The Drug code and package code are assigned by the labeler. The official FDA format for NDC number separates the 3 segments with dashes. Request for NDC Number is submitted to FDA through FDA electronic submission Gateway using SPL files with coded data fields.
Informations required for NDC Number request
- Labeler Name
- DUNS Number
- Contact Name & Address
- Labeler Address
- Business Operation
- Us Agent
FDA use DUNS number to verify the establishment address.
Address includes Street, city, State, Postal code, Country, Phone and email.
Address of the labeler including Street, city, State, Postal code and Country.
Identify the Type of business.
Each foreign establishment should have a US agent.
SPL File Submission
After preparing the SPL file for NDC Labeler code request, it is submitted to FDA via Electronic Submission Gateway (ESG). Requests for NDC Labeler Codes are individually evaluated prior to entry into the NDC system. The initial submission for NDC Labeler Code is reviewed by FDA. Once the evaluation is completed, FDA will assign the first 5 digits of the NDC Labeler code which represents the establishment. After FDA assign the labeler code, the previous SPL file is resubmitted with assigned labeler code.
|FDA Registration, US Agent, Labeler code||USD 649 (Annually)|
|Drug listing||USD 399 / Drug|
|Label Review||USD 649 / Drug|
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