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. Initial U.S. Approval: 2000
Approved
Approval ID
5d9a45c6-e234-4d56-9132-5e24e65852e6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 9, 2021
Manufacturers
FDA
Slate Run Pharmaceuticals, LLC
DUNS: 039452765
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 Code70436-025
Application NumberANDA213078
Product Classification
M
Marketing Category
C73584
G
Generic Name
bivalirudin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2021
FDA Product Classification
INGREDIENTS (3)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BIVALIRUDINActive
Quantity: 250 mg in 1 1
Code: TN9BEX005G
Classification: ACTIB