Package 57894-505-20

Brand: darzalex iv

Generic: daratumumab
NDC Package

Package Facts

Identity

Package NDC 57894-505-20
Digits Only 5789450520
Product NDC 57894-505
Product ID 57894-505_7a931e23-16ed-4112-a593-6c1a696cd4aa
Description

1 VIAL, SINGLE-DOSE in 1 BOX (57894-505-20) / 20 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2021-10-15
Brand darzalex iv
Generic daratumumab
Sample Package No

Linked Drug Pages (1)

DARZALEX, Darzalex IV ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7a931e23-16ed-4112-a593-6c1a696cd4aa", "openfda": {"nui": ["N0000192336", "N0000192335", "M0001357"], "upc": ["0357894502050"], "unii": ["4Z63YK6E0E"], "rxcui": ["1721951", "1721956", "1726439", "1726440"], "spl_set_id": ["a4d0efe9-5e54-467e-9eb4-56fa7d53b60b"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]"], "pharm_class_epc": ["CD38-directed Cytolytic Antibody [EPC]"], "pharm_class_moa": ["CD38-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Janssen Biotech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BOX (57894-505-05)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "57894-505-05", "marketing_start_date": "20211015"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BOX (57894-505-20)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "57894-505-20", "marketing_start_date": "20211015"}], "brand_name": "Darzalex IV", "product_id": "57894-505_7a931e23-16ed-4112-a593-6c1a696cd4aa", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Antibodies", "Monoclonal [CS]", "CD38-directed Antibody Interactions [MoA]", "CD38-directed Cytolytic Antibody [EPC]"], "product_ndc": "57894-505", "generic_name": "Daratumumab", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darzalex IV", "active_ingredients": [{"name": "DARATUMUMAB", "strength": "100 mg/5mL"}], "application_number": "BLA761036", "marketing_category": "BLA", "marketing_start_date": "20211015", "listing_expiration_date": "20271231"}