Any establishment engaged in the manufacture, repacking, relabeling, or salvaging of drugs for commercial distribution in the U.S., is required to register with the FDA, and list its products.
Our service includes
- Labeler Code
- National Drug Code (NDC)
- Establishment Registration
- FDA Establishment Identification (FEI) Number
- Product Listing
Lowest SERVICE FEES available here. See our offer, below.
Government fees or User Fees are paid to the U.S. Treasury, when required. Drug application fees are due when an application is submitted. Prescription drug product program fees are assessed annually for eligible products.
|Requiring clinical data||$2,875,842|
|Not requiring clinical data||$1,437,921|