Fee: $349 USD
(One-Time Fee)
FDA Labeler Code Assignment Services
A Labeler Code is a five-digit number assigned by the U.S. Food and Drug Administration (FDA) to companies that manufacture or market drug products in the United States. The Labeler Code forms the first five digits of the National Drug Code (NDC) and is required before any drug product can be listed with the FDA.
What Is a Labeler Code?
The Labeler Code uniquely identifies the firm responsible for manufacturing, repacking, or relabeling a drug product. It is a critical component of the 11-digit NDC number, which is structured as:
Labeler Code (5 digits)
Product Code
Package Code
Without an assigned Labeler Code, a company cannot legally list or market drug products in the U.S.
FDA Labeler Code Application Process
Companies must apply for a Labeler Code by submitting a request to the FDA in Structured Product Labeling (SPL) format.
During the review process, the FDA:
Verifies the company’s legal name and physical address
Confirms the information against the DUNS database
Assigns the Labeler Code upon approval
Once submitted correctly, FDA processing typically takes approximately 10 business days.
Labeler Code Assistance Services
FDA Registration Assistance provides full support for the Labeler Code request and submission process, ensuring accuracy and regulatory compliance.
Our services include:
Preparation of the Labeler Code request in SPL format
Verification of company and DUNS information
Submission to the FDA on your behalf
Regulatory support throughout the process
We help minimize delays and ensure your Labeler Code is issued correctly the first time.
To have FDA Registration Assistance obtain your FDA Labeler Code, please contact us today.
Frequently Asked Questions (FAQ)
What is an FDA Labeler Code?
An FDA Labeler Code is a five-digit number assigned to drug companies and is the first segment of the National Drug Code (NDC).
Who needs a Labeler Code?
Any company that intends to manufacture, repack, relabel, or market drug products in the United States needs a Labeler Code.
Is a Labeler Code the same as an NDC?
No. The Labeler Code is only one part of the NDC. The full NDC also includes a product code and package code.
How long does it take to obtain a Labeler Code?
FDA review and assignment typically takes about 10 business days, assuming the submission is complete and accurate.
Is a DUNS number required for a Labeler Code?
Yes. The FDA verifies company information against the DUNS database before assigning a Labeler Code.
Can FDA Registration Assistance submit the Labeler Code request for me?
Yes. FDA Registration Assistance prepares and submits the entire request on your behalf.
Contact FDA Registration Assistance
Get your FDA Labeler Code and move forward with drug product listing and compliance.
