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- What is FDA NDC Code?
- FDA – National Drugs Code
- Is a unqiue identifier for every medical substance
- Which can be imported to United States for Drugs
- FDA Maintains NDC Code database
- NDC Code has unqiue labeler code for every company
- US FDA Agent will manage for NDC Code with FDA
- Subscription Steps
- Fill the online registration form
- Make One Time Payment
- Our team collects all documents
- Dedicated A/C Manager Assigned for your work
- Weekly Update for your work
- Your US FDA NDC Code Registration Completed.
- Tracking and Monitoring
- Payment receipt sent to you by email
- Receive automatic email alerts
- One year free support
Registering a National Drug Code (NDC) with the U.S. Food and Drug Administration (FDA) is part of the drug listing process. The NDC is a unique identifier assigned to each drug product, and it is used for product identification and tracking in the United States. Here’s an overview of the process for registering an NDC code:
1. Obtain Establishment Registration: Before registering an NDC code, drug manufacturers, repackagers, relabelers, and other entities involved in drug distribution must first register their establishment with the FDA. The establishment registration is done through the FDA’s Drug Registration and Listing System (DRLS).
2. Collect Necessary Information: Gather all the required information about the drug product that will be associated with the NDC code. This information includes the drug’s active ingredient(s), strength, dosage form, route of administration, and packaging details.
3. Submit Drug Listing Information: Once your establishment is registered, you can submit the drug listing information, including the details mentioned above, to the FDA. This is done electronically through the DRLS.
4. Obtain the NDC Code: After the FDA reviews and processes your drug listing submission, you will receive the NDC code for the specific drug product. The NDC is a ten-digit number, typically presented in a three-segment format (e.g., 00000-0000-00).
5. Use the NDC Code on Product Labeling: Once you have obtained the NDC code, you are required to include it on the drug product’s labeling. The NDC code must be displayed in a human-readable format and in a standardized barcode format (if applicable).
6. Annual Renewal: Drug listings and associated NDC codes must be renewed annually. As part of the annual renewal process, you need to verify and update the drug listing information as necessary.
It’s important to ensure accuracy and compliance with FDA regulations when registering an NDC code and listing drug products. Failure to properly list drugs or comply with labeling requirements can result in regulatory action and other consequences.
For more detailed information and specific requirements related to NDC code registration and drug listing, refer to the FDA’s official website (www.fda.gov) and consult relevant guidance documents. Additionally, seeking the assistance of regulatory experts or consultants with experience in drug listing and FDA compliance can be beneficial in navigating the process successfully.