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
19a4afc5-151d-4d3c-bfef-48aa8797d695
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 20, 2020
Manufacturers
FDA
Civica, Inc.
DUNS: 081373942
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 Code72572-035
Application NumberNDA020873
Product Classification
M
Marketing Category
C73605
G
Generic Name
bivalirudin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 20, 2020
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