Package 0024-0654-01
Brand: sarclisa
Generic: isatuximabPackage Facts
Identity
Package NDC
0024-0654-01
Digits Only
0024065401
Product NDC
0024-0654
Description
1 VIAL, SINGLE-DOSE in 1 CARTON (0024-0654-01) / 5 mL in 1 VIAL, SINGLE-DOSE
Marketing
Marketing Status
Brand
sarclisa
Generic
isatuximab
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "847d3ca5-cd5b-4746-93c0-b6bf511d3d13", "openfda": {"nui": ["N0000192336", "N0000192335", "M0001357"], "unii": ["R30772KCU0"], "rxcui": ["2282023", "2282028", "2282031", "2282032"], "spl_set_id": ["a0473462-6f9d-4eca-a5bf-8620aea68e8a"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]"], "pharm_class_epc": ["CD38-directed Cytolytic Antibody [EPC]"], "pharm_class_moa": ["CD38-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Sanofi-Aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0024-0654-01) / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0024-0654-01", "marketing_start_date": "20200302"}], "brand_name": "Sarclisa", "product_id": "0024-0654_847d3ca5-cd5b-4746-93c0-b6bf511d3d13", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Antibodies", "Monoclonal [CS]", "CD38-directed Antibody Interactions [MoA]", "CD38-directed Cytolytic Antibody [EPC]"], "product_ndc": "0024-0654", "generic_name": "isatuximab", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sarclisa", "active_ingredients": [{"name": "ISATUXIMAB", "strength": "100 mg/5mL"}], "application_number": "BLA761113", "marketing_category": "BLA", "marketing_start_date": "20200302", "listing_expiration_date": "20261231"}