Package 52958-034-01
Brand: bivalirudin
Generic: bivalirudinPackage Facts
Identity
Package NDC
52958-034-01
Digits Only
5295803401
Product NDC
52958-034
Description
10 VIAL, SINGLE-USE in 1 CARTON (52958-034-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
Marketing
Marketing Status
Brand
bivalirudin
Generic
bivalirudin
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "463422b6-e6d2-4319-a95e-aed834c2c844", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "upc": ["0352958034010"], "unii": ["TN9BEX005G"], "rxcui": ["308769"], "spl_set_id": ["61de12ff-e280-4bab-9804-43869ec45fa7"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Hainan Shuangcheng Pharmaceuticals Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CARTON (52958-034-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE", "package_ndc": "52958-034-01", "marketing_start_date": "20191023"}], "brand_name": "Bivalirudin", "product_id": "52958-034_463422b6-e6d2-4319-a95e-aed834c2c844", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "52958-034", "generic_name": "Bivalirudin", "labeler_name": "Hainan Shuangcheng Pharmaceuticals Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bivalirudin", "active_ingredients": [{"name": "BIVALIRUDIN", "strength": "250 mg/1"}], "application_number": "ANDA210031", "marketing_category": "ANDA", "marketing_start_date": "20191023", "listing_expiration_date": "20261231"}