BELRAPZO
These highlights do not include all the information needed to use BELRAPZO safely and effectively. See full prescribing information for BELRAPZO. BELRAPZO (bendamustine hydrochloride injection), for intravenous use. Initial U.S. Approval: 2008
Approved
Approval ID
9759a4ae-82ca-40cf-9c02-e1cadb21cbdc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2024
Manufacturers
FDA
Eagle Pharmaceuticals, Inc
DUNS: 849818161
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 Code42367-521
Application NumberNDA205580
Product Classification
M
Marketing Category
C73594
G
Generic Name
bendamustine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 9, 2019
FDA Product Classification
INGREDIENTS (5)
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
BENDAMUSTINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 981Y8SX18M
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MONOTHIOGLYCEROLInactive
Code: AAO1P0WSXJ
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT