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
NDC Product Code70436-025
Application NumberANDA213078
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2021
Generic Namebivalirudin
INGREDIENTS (3)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BIVALIRUDINActive
Quantity: 250 mg in 1 1
Code: TN9BEX005G
Classification: ACTIB