Package 66302-014-01

Brand: unituxin

Generic: dinutuximab
NDC Package

Package Facts

Identity

Package NDC 66302-014-01
Digits Only 6630201401
Product NDC 66302-014
Description

1 VIAL, SINGLE-DOSE in 1 BOX (66302-014-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2015-03-10
Brand unituxin
Generic dinutuximab
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "b841106b-07b0-473b-9da9-a91b4363e3b4", "openfda": {"nui": ["N0000191500", "N0000191499"], "unii": ["7SQY4ZUD30"], "rxcui": ["1606278", "1606283"], "spl_set_id": ["d66bdf0d-9d65-45de-ae5b-a58617c27492"], "pharm_class_epc": ["Glycolipid Disialoganglioside-directed Antibody [EPC]"], "pharm_class_moa": ["Glycolipid Disialoganglioside-directed Antibody Interactions [MoA]"], "manufacturer_name": ["United Therapeutics Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BOX (66302-014-01)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "66302-014-01", "marketing_start_date": "20150310"}], "brand_name": "Unituxin", "product_id": "66302-014_b841106b-07b0-473b-9da9-a91b4363e3b4", "dosage_form": "INJECTION", "pharm_class": ["Glycolipid Disialoganglioside-directed Antibody Interactions [MoA]", "Glycolipid Disialoganglioside-directed Antibody [EPC]"], "product_ndc": "66302-014", "generic_name": "DINUTUXIMAB", "labeler_name": "United Therapeutics Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Unituxin", "active_ingredients": [{"name": "DINUTUXIMAB", "strength": "3.5 mg/mL"}], "application_number": "BLA125516", "marketing_category": "BLA", "marketing_start_date": "20150310", "listing_expiration_date": "20261231"}