Package 50242-127-01
Brand: columvi
Generic: glofitamabPackage Facts
Identity
Package NDC
50242-127-01
Digits Only
5024212701
Product NDC
50242-127
Description
1 VIAL, SINGLE-DOSE in 1 CARTON (50242-127-01) / 10 mL in 1 VIAL, SINGLE-DOSE
Marketing
Marketing Status
Brand
columvi
Generic
glofitamab
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "5e794f49-9344-4145-82e3-c2f7f96988c5", "openfda": {"nui": ["N0000194063", "N0000175078", "N0000175617", "N0000175618", "N0000009267", "N0000182136"], "unii": ["06P3KLK2J8"], "rxcui": ["2639786", "2639792", "2639794", "2639795"], "spl_set_id": ["3516e753-f064-4d30-9bd5-e3f2e143f75d"], "pharm_class_pe": ["Increased Cytokine Activity [PE]"], "pharm_class_epc": ["Bispecific CD20-directed CD3 T Cell Engager [EPC]"], "pharm_class_moa": ["CD20-directed Antibody Interactions [MoA]", "CD3-directed Antibody Interactions [MoA]", "CD3 Receptor Agonists [MoA]", "Cytochrome P450 Inhibitors [MoA]"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (50242-127-01) / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50242-127-01", "marketing_start_date": "20230615"}], "brand_name": "Columvi", "product_id": "50242-127_5e794f49-9344-4145-82e3-c2f7f96988c5", "dosage_form": "CONCENTRATE", "pharm_class": ["Bispecific CD20-directed CD3 T Cell Engager [EPC]", "CD20-directed Antibody Interactions [MoA]", "CD3 Receptor Agonists [MoA]", "CD3-directed Antibody Interactions [MoA]", "Cytochrome P450 Inhibitors [MoA]", "Increased Cytokine Activity [PE]"], "product_ndc": "50242-127", "generic_name": "Glofitamab", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Columvi", "active_ingredients": [{"name": "GLOFITAMAB", "strength": "10 mg/10mL"}], "application_number": "BLA761309", "marketing_category": "BLA", "marketing_start_date": "20230615", "listing_expiration_date": "20261231"}