Package 71288-427-11

Brand: bivalirudin

Generic: bivalirudin
NDC Package

Package Facts

Identity

Package NDC 71288-427-11
Digits Only 7128842711
Product NDC 71288-427
Description

10 VIAL, SINGLE-DOSE in 1 CARTON (71288-427-11) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-427-10)

Marketing

Marketing Status
Marketed Since 2018-07-16
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": "2b20b742-4bab-4e5b-9d1b-9a7ca9e0daf7", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "unii": ["TN9BEX005G"], "rxcui": ["308769"], "spl_set_id": ["4119b710-ef30-4e3e-b99a-38e42b4b3fca"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (71288-427-11)  / 5 mL in 1 VIAL, SINGLE-DOSE (71288-427-10)", "package_ndc": "71288-427-11", "marketing_start_date": "20180716"}], "brand_name": "BIVALIRUDIN", "product_id": "71288-427_2b20b742-4bab-4e5b-9d1b-9a7ca9e0daf7", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "71288-427", "generic_name": "BIVALIRUDIN", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BIVALIRUDIN", "active_ingredients": [{"name": "BIVALIRUDIN", "strength": "250 mg/5mL"}], "application_number": "ANDA091602", "marketing_category": "ANDA", "marketing_start_date": "20180716", "listing_expiration_date": "20261231"}