FDA Drug Establishment Registration – NDC Code Form

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Description of Service and Cost

Services

Drug Establishment Registration, Labeler code, SPL preparation, Submission and US Agent.

Fees

USD 649
(Annually)

Number of services
Total Fees

Drug Listing

USD 399 / Drug

Label Review

USD 649 / Drug

Type of Submission (select one or both)
Type of Submission (select one or both)
Establishment (Please provide the actual manufacturing/Processing facility address if the type of submission is drug establishment registration.)
Address
Establishment Contact
Mailing Address
Type of Operation
Type of Operation
Drug Status
Drug Status
US Importer / Distributor
Address