Package 50242-554-01

{"route": ["SUBCUTANEOUS"], "spl_id": "3ec82250-b360-43e5-8d94-b4c36a0542a8", "openfda": {"nui": ["N0000175531", "M0009499", "N0000175078", "N0000175657", "M0001357", "M0556300"], "unii": ["743QUY4VD8", "A10SJL62JY"], "rxcui": ["2693458", "2693465"], "spl_set_id": ["b216af61-99d0-42a3-afc2-b5bf86df1ec0"], "pharm_class_cs": ["Glycoside Hydrolases [CS]", "Antibodies, Monoclonal [CS]", "Antibodies, Monoclonal, Humanized [CS]"], "pharm_class_epc": ["Endoglycosidase [EPC]", "CD20-directed Cytolytic Antibody [EPC]"], "pharm_class_moa": ["CD20-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (50242-554-01)  / 23 mL in 1 VIAL, SINGLE-USE", "package_ndc": "50242-554-01", "marketing_start_date": "20240913"}, {"sample": true, "description": "1 VIAL, SINGLE-USE in 1 CARTON (50242-554-86)  / 23 mL in 1 VIAL, SINGLE-USE", "package_ndc": "50242-554-86", "marketing_start_date": "20240913"}], "brand_name": "Ocrevus Zunovo", "product_id": "50242-554_3ec82250-b360-43e5-8d94-b4c36a0542a8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "Antibodies", "Monoclonal", "Humanized [CS]", "CD20-directed Antibody Interactions [MoA]", "CD20-directed Cytolytic Antibody [EPC]", "Endoglycosidase [EPC]", "Glycoside Hydrolases [CS]"], "product_ndc": "50242-554", "generic_name": "ocrelizumab and hyaluronidase", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ocrevus Zunovo", "active_ingredients": [{"name": "HYALURONIDASE (HUMAN RECOMBINANT)", "strength": "23000 U/23mL"}, {"name": "OCRELIZUMAB", "strength": "920 mg/23mL"}], "application_number": "BLA761371", "marketing_category": "BLA", "marketing_start_date": "20240913", "listing_expiration_date": "20261231"}