FDA Drug Listing & NDC Number Registration Services
Drug Listing and NDC number assignment services
Every drug product sold in the United States must be listed with the FDA and assigned a National Drug Code (NDC) number. This is not optional. The Drug Listing Act of 1972 requires all registered drug companies to provide the FDA with detailed information about any drug product made for commercial distribution. Drug listing applies to prescription drugs, OTC drugs, and bulk drug substances. If your product is not listed, it cannot legally be marketed in the US.
What is an NDC number?
The NDC number is a unique three-segment identifier assigned to every drug product. The first segment identifies the labeler (your company), the second identifies the specific product, and the third identifies the package size and type. Before you can obtain NDC numbers for your products, you need a labeler code from the FDA. And before you can get a labeler code, your drug establishment must be registered. The sequence matters, and FDABasics handles all of it.
What the drug listing process involves
Drug listing is more involved than most companies expect. Here is what the process requires:
For OTC products sold through e-commerce, there are additional labeling and listing considerations. FDABasics advises on these as part of our standard service.
One important thing to know
The FDA does not issue certificates for drug listings. Any certificate offered by a consulting firm is not a valid FDA document. Your drug listing is confirmed through the FDA's online databases, and FDABasics will show you exactly where to verify your listing once it is complete.
How FDABasics can help
We handle the entire drug listing process from start to finish, including facility registration, labeler code application, NDC number assignment, SPL file preparation, and submission to the FDA. We explain every step in plain English, respond quickly, and make sure the details are right before anything is submitted. Services start from $299 with no hidden fees. Discounts are available for multiple drug listings.
Ready to get started? Complete the short form on our website and we will be in touch promptly.
Get Started with these Top Drug Establishment Forms
- US Agent for Foreign Establishment
- Drug Establishment Registration Form
- NDC Labeler Code Form
- Drug Listing Form
- GDUFA Self Identification Form
- Drug Establishment FEI Number Form
Why Choose FDABasics?
FDABasics has been helping foreign manufacturers navigate US FDA requirements since 1995, with over 30 years of regulatory experience serving clients across the food, drug, medical device, and cosmetics industries. We are headquartered in New York, USA and combine deep expertise with the most competitive fees in the industry.
30+ Years of Experience
Originally founded in 1995 as Tobias Systems, we have guided thousands of foreign companies through FDA registration, US Agent services, and full compliance across all four regulated industries.
5-Star Rated on Trustpilot and Google
Our clients consistently rate us 5 stars on both Trustpilot and Google for fast turnaround times, clear communication, and expert handling of their FDA compliance needs.
Strict Client Confidentiality
We believe in ethical business practices and maintain strict confidentiality for all clients. We do not share your information and we do not offer advice simply to sell services.
Lowest Fees, No Hidden Charges
Our fees are straightforward with no hidden charges. We guarantee a cost-effective solution for your business, whether you are a startup or an established manufacturer.
Fast Turnaround and Responsive Service
We know that FDA registration issues can hold up your shipments and delay your market entry. We work quickly and respond promptly so that your compliance is never a bottleneck for your business.
Global Clients, US-Based Team
We serve manufacturers from over 100+ countries and are physically located in the United States, which is a legal requirement for any company serving as your official US FDA Agent.
Not Sure Where To Start?
FDA compliance requirements can be complex, and the right path depends on your specific product, your role in the supply chain, and whether you are a foreign or domestic company. The FDABasics team is happy to point you in the right direction. Contact us for a free consultation and we will help you identify exactly what your business needs to stay compliant and keep products moving into the US market.
