bendamustine hydrochloride
These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for Injection, for intravenous use Initial U.S. Approval: 2008
Approved
Approval ID
33867f0f-f317-1fd0-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2022
Manufacturers
FDA
Accord Healthcare, Inc.
DUNS: 604222237
Products 2
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 Code16729-251
Application NumberANDA205574
Product Classification
M
Marketing Category
C73584
G
Generic Name
bendamustine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 8, 2022
FDA Product Classification
INGREDIENTS (2)
BENDAMUSTINE HYDROCHLORIDEActive
Quantity: 100 mg in 20 mL
Code: 981Y8SX18M
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
bendamustine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-250
Application NumberANDA205574
Product Classification
M
Marketing Category
C73584
G
Generic Name
bendamustine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 8, 2022
FDA Product Classification
INGREDIENTS (2)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
BENDAMUSTINE HYDROCHLORIDEActive
Quantity: 25 mg in 5 mL
Code: 981Y8SX18M
Classification: ACTIB