FDA Drug Establishment Registration - NDC Code Form

Description of Service and Cost
 Services  Fees  Number of services  Total Fees
 Drug Establishment Registration,
 Labeler code, SPL preparation,
 Submission and US Agent.
 USD 649
 Drug Listing
 USD 399 / Drug
 Label Review (Optional)
 USD 649 / Drug
Total    $  
Type of Submission (select one or both)
Drug Establishment Registration               Labeler Code Request
Establishment Contact
Type of Operation
Manufacture               Repack                          Relabel                          API Manufacture               Private Label Distribution
Analytical Lab            Sterilize                               
Drug Status
OTC                               Prescription                  API                                 Veterinary                          Homeopathic
US Importer / Distributor

Submitter Name        Job Title        Submitter E-mail