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  • What are the different document types that can be submitted through the CDER DIRECT portal?
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  • The following document types are currently available through CDER DIRECT at this time: o NDC Labeler Code Request • NDC Labeler Code Inactivation o Establishment Registration • No Change Notification • Out of Business Notification • Establishment De-Registration o Product Listing • Bulk Ingredient • Cellular Therapy • Human OTC Drug Label • Human Prescription Drug Label • Human Compounder Drug Label • Non-Standardized Allergenic Label • Plasma Derivative • Standardized Allergenic • Vaccine Label o Whole Sale Drug Distributors / Third Party Logistics • WHOLESALE DRUG DISTRIBUTORS AND THIRD-PARTY LOGISTICS FACILITY REPORT • Out Of Business Notification • Withdrawal of Wholesale Drug Distributors and Third-Party Logistics Provider Report