Package 0008-0100-01

Brand: besponsa

Generic: inotuzumab ozogamicin
NDC Package

Package Facts

Identity

Package NDC 0008-0100-01
Digits Only 0008010001
Product NDC 0008-0100
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2017-08-18
Brand besponsa
Generic inotuzumab ozogamicin
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "427d10d2-c29d-4b71-a5fe-c97736d59aa6", "openfda": {"nui": ["N0000193617", "N0000193616", "N0000008576", "N0000009176", "M0028142"], "unii": ["P93RUU11P7"], "rxcui": ["1942954", "1942959"], "spl_set_id": ["cc7014b1-c775-411d-b374-8113248b4077"], "pharm_class_cs": ["Immunoconjugates [CS]"], "pharm_class_pe": ["Decreased DNA Integrity [PE]", "Increased Cellular Death [PE]"], "pharm_class_epc": ["CD22-directed Immunoconjugate [EPC]"], "pharm_class_moa": ["CD22-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 (0008-0100-01)  / 4 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0008-0100-01", "marketing_start_date": "20170818"}], "brand_name": "Besponsa", "product_id": "0008-0100_427d10d2-c29d-4b71-a5fe-c97736d59aa6", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["CD22-directed Antibody Interactions [MoA]", "CD22-directed Immunoconjugate [EPC]", "Decreased DNA Integrity [PE]", "Immunoconjugates [CS]", "Increased Cellular Death [PE]"], "product_ndc": "0008-0100", "generic_name": "inotuzumab ozogamicin", "labeler_name": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Besponsa", "active_ingredients": [{"name": "INOTUZUMAB OZOGAMICIN", "strength": ".25 mg/mL"}], "application_number": "BLA761040", "marketing_category": "BLA", "marketing_start_date": "20170818", "listing_expiration_date": "20271231"}