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) Please Enter $ Drug Listing USD 399 / Drug Please Enter $ Label Review USD 649 / Drug Please Enter $ 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 Name
* Street Address
* City				* State
* Country				* Postal Code
FDA Registration Number (Optional, If Any)				DUNS Number (Mandatory)
Establishment Contact
* Contact Person Name				* Job Title
* Mailing Address
* City				* State
* Country				* Postal Code
* E-mail				* Tel Number
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
* Other (explain)
Drug Status
OTC Prescription API Veterinary Homeopathic
US Importer / Distributor
US Importer Name
FDA Registration Number				DUNS Number
Address
E-mail				Tel Number
I agree to the above Terms and Conditions
Submitter Name    Job Title    Submitter E-mail