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
42aa2630-83d6-433d-8277-0f672cf8d71d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2023
Manufacturers
FDA
Avenacy, Inc.
DUNS: 119060628
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 Code83634-400
Application NumberANDA210031
Product Classification
M
Marketing Category
C73584
G
Generic Name
bivalirudin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 18, 2023
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