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
(Annually)
$
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 (Please provide the actual manufacturing/Processing facility address if the type of submission is drug establishment registration.)
Establishment Contact
Type of Operation
Manufacture Contract Manufacture Label Pack Repack Relabel API Manufacture Private Label Distribution
Analytical Lab Sterilize API/FDF analytical testing Clinical bioequivalence or bioavailability study
In vitro bioequivalence or bioanalytical testing FDF manufacture Human drug compounding outsourcing facility
Drug Status
OTC Prescription API Veterinary Homeopathic
US Importer / Distributor

Submitter Name    Job Title    Submitter E-mail