Services to Ease FDA Regulatory Compliance

FDA Drug Listing & NDC Number Registration Services

The Drug Listing Act of 1972 requires all registered drug companies to provide the FDA with detailed information about any drug products made for commercial distribution.  To keep track, drug products are assigned a unique identifier, called the National Drug Code – or NDC – number.

It is a mandatory requirement for drug companies to register their manufacturing facility and list the drugs under commercial distribution.

Pragmatic offers a complete solution for establishment registration, labeler code, NDC number assignment and drug listing services. We also provide complete assistance for OTC, Prescription and  Bulk drug listing services:

  • Obtaining a DUNS number
  • Appointing a US agent
  • Registering the manufacturing facility
  • Obtaining a labeler code from the FDA
  • Assigning NDC numbers for products, based on product type and pack strength
  • Developing proper labeling for the product
  • Completing the drug listing process.
  • Advising on OTC drug selling on an e-commerce portal

Services start from as little as $299, with no hidden charges. We also offer discounts for multiple drug listings.

Why choose Pragmatic for drug listing services?
  • We provide a complete solution for all your regulatory compliance needs
  • We assure transparency across all our services
  • We offer cost-effective rates, with no hidden charges
  • We deliver effective, high-quality service: the drug listing processes takes just three to four working days
  • We draw on our extensive experience to advise companies about drugs categories
  • We offer a free evaluation on drug listing to identify the proper classification
  • We will continue to support you until your drug listing has been verified on the FDA website.

Check out our FAQs if you have any questions, or contact us.

Remember: the FDA does not issue certificates for drugs listings. All listings are available on line. Certificates issued by consulting firms are not valid.

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