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 useInitial U.S. Approval: 2000
Approved
Approval ID
95d150e7-f152-4091-b831-e469c9578a54
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2021
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
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 Code67457-256
Application NumberANDA202471
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMarch 7, 2017
Generic Namebivalirudin
INGREDIENTS (3)
MANNITOLInactive
Quantity: 125 mg in 5 mL
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BIVALIRUDINActive
Quantity: 250 mg in 5 mL
Code: TN9BEX005G
Classification: ACTIB