VIVIMUSTA
These highlights do not include all the information needed to use VIVIMUSTA safely and effectively. See full prescribing information for VIVIMUSTA. VIVIMUSTA® (bendamustine hydrochloride injection), for intravenous use. Initial U.S. Approval: 2008
Approved
Approval ID
4df6548f-c4ad-4eb2-a54f-19766a3d90ca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 28, 2025
Manufacturers
FDA
Azurity Pharmaceuticals, Inc.
DUNS: 117505635
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BENDAMUSTINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-270
Application NumberNDA212209
Product Classification
M
Marketing Category
C73594
G
Generic Name
BENDAMUSTINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 28, 2025
FDA Product Classification
INGREDIENTS (5)
BENDAMUSTINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 mL
Code: 981Y8SX18M
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
MONOTHIOGLYCEROLInactive
Code: AAO1P0WSXJ
Classification: IACT