Package 0008-4510-01
Brand: mylotarg
Generic: gemtuzumab ozogamicinPackage Facts
Identity
Package NDC
0008-4510-01
Digits Only
0008451001
Product NDC
0008-4510
Description
1 VIAL, SINGLE-DOSE in 1 CARTON (0008-4510-01) / 5 mL in 1 VIAL, SINGLE-DOSE
Marketing
Marketing Status
Brand
mylotarg
Generic
gemtuzumab ozogamicin
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "ef242018-af2a-4c03-99b7-908e2610f86f", "openfda": {"nui": ["N0000175571", "N0000175077"], "unii": ["8GZG754X6M"], "rxcui": ["1944701", "1944704"], "spl_set_id": ["32fd2bb2-1cfa-4250-feb8-d7956c794e05"], "pharm_class_epc": ["CD33-directed Immunoconjugate [EPC]"], "pharm_class_moa": ["CD33-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0008-4510-01) / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0008-4510-01", "marketing_start_date": "20170907"}], "brand_name": "Mylotarg", "product_id": "0008-4510_ef242018-af2a-4c03-99b7-908e2610f86f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["CD33-directed Antibody Interactions [MoA]", "CD33-directed Immunoconjugate [EPC]"], "product_ndc": "0008-4510", "generic_name": "gemtuzumab ozogamicin", "labeler_name": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mylotarg", "active_ingredients": [{"name": "GEMTUZUMAB OZOGAMICIN", "strength": "5 mg/5mL"}], "application_number": "BLA761060", "marketing_category": "BLA", "marketing_start_date": "20170907", "listing_expiration_date": "20261231"}