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
61de12ff-e280-4bab-9804-43869ec45fa7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 20, 2019
Manufacturers
FDA
Hainan Shuangcheng Pharmaceuticals Co., Ltd.
DUNS: 421282282
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 Code52958-034
Application NumberANDA210031
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bivalirudin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 17, 2020
FDA Product Classification
INGREDIENTS (3)
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
BivalirudinActive
Quantity: 250 mg in 1 1
Code: TN9BEX005G
Classification: ACTIB
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT