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
af943fa0-ab0f-4b62-9ff0-54ee24cdb772
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2021
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bivalirudin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-562
Application NumberANDA090189
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bivalirudin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 28, 2016
FDA Product Classification
INGREDIENTS (3)
BIVALIRUDINActive
Quantity: 250 mg in 1 1
Code: TN9BEX005G
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT