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NDC/NHRIC Labeler Codes | FDA
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The National Health Related Items Code (NHRIC) is a system for identification and numbering of marketed device packages that is compatible with other numbering systems such as the National Drug Code (NDC) or Universal Product Code (UPC).

In order to obtain NDC Labeler code the drug manufacturers should submit a request in SPL (Structured Product Labeling) format via FDA's Electronic Submission Gateway or ESG. In order to successfully submit the SPL drug manufacturers also should have a U.S. agent. FDA Listing Inc.

Process for requesting a labeler code Leave the NDC labeler code field blank. FDA will email the contact person on the request with the assigned number. Submit an updated labeler code form SPL as described below with the newly assigned number filled in to complete the process.

NDC Number Each listed drug product listed is assigned a unique 10-digit, 3-segment number. This number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA.

It will take about ten business days to obtain a labeler code, and after the labeler code is assigned, it will take 2 to 3 business days, to complete the drug listing process.

This number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug.

The Labeler Code is the first five numeric characters of the NDC or the first six numeric characters when the available five-character code combinations are exhausted.

Do I need a labeler code? Labeler codes are only used for generating National Drug Code (NDC) numbers for drugs. Generally, if you do not have to list any drugs with FDA, you do not need to apply for a labeler code.

In order to obtain NDC Labeler code the drug manufacturers should submit a request in SPL (Structured Product Labeling) format via FDA's Electronic Submission Gateway or ESG. In order to successfully submit the SPL drug manufacturers also should have a U.S. agent.

New NDC Number Format NDC labeler code is a ten digit unique, three-segment number which serves as a product identifier for human drugs. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232