Package 44087-3535-1

Brand: bavencio

Generic: avelumab
NDC Package

Package Facts

Identity

Package NDC 44087-3535-1
Digits Only 4408735351
Product NDC 44087-3535
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (44087-3535-1) / 10 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2017-03-23
Brand bavencio
Generic avelumab
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "8e1f3b1c-5aab-408c-930e-619daa6afa8a", "openfda": {"nui": ["N0000193338", "N0000193337", "N0000193336", "M0001357"], "unii": ["KXG2PJ551I"], "rxcui": ["1875542", "1875547"], "spl_set_id": ["5cd725a1-2fa4-408a-a651-57a7b84b2118"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]"], "pharm_class_epc": ["Programmed Death Ligand-1 Blocker [EPC]"], "pharm_class_moa": ["Programmed Death Ligand-1 Antagonists [MoA]", "Programmed Death Ligand-1-directed Antibody Interactions [MoA]"], "manufacturer_name": ["EMD Serono, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (44087-3535-1)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "44087-3535-1", "marketing_start_date": "20170323"}], "brand_name": "BAVENCIO", "product_id": "44087-3535_8e1f3b1c-5aab-408c-930e-619daa6afa8a", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Antibodies", "Monoclonal [CS]", "Programmed Death Ligand-1 Antagonists [MoA]", "Programmed Death Ligand-1 Blocker [EPC]", "Programmed Death Ligand-1-directed Antibody Interactions [MoA]"], "product_ndc": "44087-3535", "generic_name": "avelumab", "labeler_name": "EMD Serono, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BAVENCIO", "active_ingredients": [{"name": "AVELUMAB", "strength": "20 mg/mL"}], "application_number": "BLA761049", "marketing_category": "BLA", "marketing_start_date": "20170323", "listing_expiration_date": "20261231"}