Drug Listing
Stay Compliant and Keep Your Drug Products Moving into the U.S. Market
To legally market human and animal drugs in the United States, every manufacturer, repacker, or relabeler must list each drug product with the FDA. This process is required under the Federal Food, Drug, and Cosmetic Act (FD&C Act), specifically Sections 510 and 510(j) 21 U.S.C. § 360 and 21 CFR Part 207.
Drug listing ensures that your products appear in the FDA’s National Drug Code (NDC) Directory, making them eligible for lawful distribution and easier for regulators, healthcare providers, and supply chain partners to track. It also helps protect public safety by maintaining accurate product information, including formulation, labeling, and manufacturing site details.
At Hykkon, we help streamline the drug listing process by reviewing your product details, preparing your submissions, and managing renewals or updates, so your business can focus on growth rather than paperwork.
What You’ll Need to Provide:
- Labeler name and DUNS number (must match your NDC labeler code)
- Contact person details
- Manufacturer name and DUNS number
- Proprietary (brand) name and suffix, labeler code, package type, and quantity
- Images of the outer package label
- DEA schedule (if applicable)
- Product characteristics: route of administration, flavor, shape, scoring, imprint, color, size, dosage form, marketing category, and marketing start date
- Detailed list of active ingredients, strength, and UNII (Unique Ingredient Identifier)
- Other relevant product information if applicable
This information helps us ensure your listing is accurate and compliant, avoiding potential delays, FDA warning letters, or market disruptions.
Ready to List Your Drug Products?
Complete the form below and let Hykkon handle the rest.
We’ll help ensure your products meet FDA listing requirements, avoid costly delays, and stay compliant year-round.
