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 useInitial U.S. Approval: 2008
Approved
Approval ID
5de3a3b3-7acd-7f0b-ecc4-60d544484149
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 20, 2023
Manufacturers
FDA
Apotex Corp
DUNS: 845263701
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 Code60505-6096
Application NumberANDA204230
Product Classification
M
Marketing Category
C73584
G
Generic Name
bendamustine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 20, 2023
FDA Product Classification
INGREDIENTS (2)
BENDAMUSTINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 981Y8SX18M
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
Bendamustine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-6095
Application NumberANDA204230
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bendamustine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 20, 2023
FDA Product Classification
INGREDIENTS (2)
BENDAMUSTINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 981Y8SX18M
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT