Package 83634-400-10
Brand: bivalirudin
Generic: bivalirudinPackage Facts
Identity
Package NDC
83634-400-10
Digits Only
8363440010
Product NDC
83634-400
Description
10 VIAL, SINGLE-DOSE in 1 CARTON (83634-400-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-400-41)
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": "f893cc33-8b26-4b98-848d-61daf2e93a2c", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "unii": ["TN9BEX005G"], "rxcui": ["308769"], "spl_set_id": ["42aa2630-83d6-433d-8277-0f672cf8d71d"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Avenacy, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (83634-400-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-400-41)", "package_ndc": "83634-400-10", "marketing_start_date": "20231218"}], "brand_name": "Bivalirudin", "product_id": "83634-400_f893cc33-8b26-4b98-848d-61daf2e93a2c", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "83634-400", "generic_name": "bivalirudin", "labeler_name": "Avenacy, Inc.", "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": "20231218", "listing_expiration_date": "20261231"}