BIVALIRUDIN
These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000
Approved
Approval ID
e574d04f-67b4-4a84-9d66-8c2d54f95120
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 23, 2023
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BIVALIRUDIN
PRODUCT DETAILS
NDC Product Code55150-210
Application NumberANDA205962
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateAugust 23, 2023
Generic NameBIVALIRUDIN
INGREDIENTS (3)
BIVALIRUDINActive
Quantity: 250 mg in 1 1
Code: TN9BEX005G
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT