Package 0024-0656-01

Brand: sarclisa

Generic: isatuximab
NDC Package

Package Facts

Identity

Package NDC 0024-0656-01
Digits Only 0024065601
Product NDC 0024-0656
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (0024-0656-01) / 25 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2020-03-02
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 (0024-0656-01)  / 25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0024-0656-01", "marketing_start_date": "20200302"}], "brand_name": "Sarclisa", "product_id": "0024-0656_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": "0024-0656", "generic_name": "isatuximab", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sarclisa", "active_ingredients": [{"name": "ISATUXIMAB", "strength": "500 mg/25mL"}], "application_number": "BLA761113", "marketing_category": "BLA", "marketing_start_date": "20200302", "listing_expiration_date": "20261231"}