Package 0597-0197-05

Brand: praxbind

Generic: idarucizumab
NDC Package

Package Facts

Identity

Package NDC 0597-0197-05
Digits Only 0597019705
Product NDC 0597-0197
Product ID 0597-0197_9474d542-4726-4546-a768-10d418cdf5cc
Description

2 VIAL, SINGLE-DOSE in 1 CARTON (0597-0197-05) / 50 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2015-10-21
Brand praxbind
Generic idarucizumab
Sample Package No

Linked Drug Pages (1)

Praxbind ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9474d542-4726-4546-a768-10d418cdf5cc", "openfda": {"nui": ["N0000191873", "M0556300"], "unii": ["97RWB5S1U6"], "rxcui": ["1716195", "1716200"], "spl_set_id": ["c7400f8a-dcf4-a6df-6d07-983081b1bf34"], "pharm_class_cs": ["Antibodies, Monoclonal, Humanized [CS]"], "pharm_class_epc": ["Humanized Monoclonal Antibody Fragment [EPC]"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 VIAL, SINGLE-DOSE in 1 CARTON (0597-0197-05)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0597-0197-05", "marketing_start_date": "20151021"}], "brand_name": "Praxbind", "product_id": "0597-0197_9474d542-4726-4546-a768-10d418cdf5cc", "dosage_form": "INJECTION", "pharm_class": ["Antibodies", "Monoclonal", "Humanized [CS]", "Humanized Monoclonal Antibody Fragment [EPC]"], "product_ndc": "0597-0197", "generic_name": "idarucizumab", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Praxbind", "active_ingredients": [{"name": "IDARUCIZUMAB", "strength": "50 mg/mL"}], "application_number": "BLA761025", "marketing_category": "BLA", "marketing_start_date": "20151021", "listing_expiration_date": "20261231"}