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How to obtain NDC number?
What is NDC number?
The National Drug Code (NDC) is a unique, 10-digit identification number assigned to every drug product in the U.S. market, whether over-the-counter (OTC) or prescription. The NDC serves several vital purposes, including its primary use in medical billing and insurance claims processing. It is also an essential piece of documentation for proving a drug’s FDA registration.
The 10-digit NDC is divided into three distinct segments:
Labeler Code (the first 5 digits) – Assigned by the FDA to identify the manufacturer, packer, or distributor of the drug product.
Product Code (the middle 4 digits) – Assigned by the labeler to represent a specific drug product, including its formulation and dosage form.
Package Code (the last 1 digit) – Represents the package size and type of drug packaging.
How to Obtain a Labeler Code?
To obtain an NDC labeler code, and successfully submit the FDA application, the applicant must have the firm’s DUNS number (Data Universal Numbering System). The DUNS record must precisely match the data submitted in the labeler code application. The Structured Product Labeling (SPL) request must be submitted through one of the FDA’s designated portals: ESG (Electronic Submission Gateway) or CDER Direct. Submissions via email or paper formats are no longer accepted. Key steps in the labeler code application process include:
Submit the FDA Labeler Code Application – The applicant must complete and submit the request electronically through the appropriate portal.
Respond to FDA Inquiries – The FDA may contact the applicant for further clarification or to address any issues with the submission.
Labeler Code Assignment – Once the submission is validated, the FDA will assign a unique labeler code.
Labeler Code Activation – The code becomes active once all information is verified and accepted.
Essential Considerations for Obtaining a Labeler Code
Processing Time: The assignment of the labeler code typically takes up to 10 business days. During this time, the FDA may reach out to verify information.
Rejection of Application: The FDA may reject an incomplete or inaccurate application. It’s essential to ensure all data is accurate and well-documented to avoid delays.
Foreign Applicants: If the applicant is based outside the U.S., they must appoint a U.S. agent to handle communications with the FDA. This ensures compliance with FDA regulations and facilitates smooth processing.
Need Help with Labeler Code Application?
Navigating the FDA’s labeler code application process can be complex. At FDA Listing Inc., we offer expert assistance to guide your firm through submission and ensure your application is completed accurately. Additionally, we can serve as your U.S. agent for seamless FDA communications. For further assistance, contact us today.
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