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TREANDA

These highlights do not include all the information needed to use TREANDA safely and effectively. See full prescribing information for TREANDA. TREANDA (bendamustine hydrochloride) injection, for intravenous useTREANDA(bendamustine hydrochloride) for injection, for intravenous useInitial U.S. Approval: 2008

Approved
Approval ID

39d53698-57fa-7c99-fc5b-f52a55684826

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 27, 2022

Manufacturers
FDA

Cephalon, LLC

DUNS: 183236314

Products 4

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 Code63459-391
Application NumberNDA022249
Product Classification
M
Marketing Category
C73594
G
Generic Name
Bendamustine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 27, 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 Code63459-396
Application NumberNDA022249
Product Classification
M
Marketing Category
C73594
G
Generic Name
Bendamustine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 27, 2022
FDA Product Classification

INGREDIENTS (3)

PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BENDAMUSTINE HYDROCHLORIDEActive
Quantity: 180 mg in 2 mL
Code: 981Y8SX18M
Classification: ACTIB
N,N-DIMETHYLACETAMIDEInactive
Code: JCV5VDB3HY
Classification: IACT

Bendamustine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63459-390
Application NumberNDA022249
Product Classification
M
Marketing Category
C73594
G
Generic Name
Bendamustine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 27, 2022
FDA Product Classification

INGREDIENTS (2)

BENDAMUSTINE HYDROCHLORIDEActive
Quantity: 25 mg in 5 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 Code63459-395
Application NumberNDA022249
Product Classification
M
Marketing Category
C73594
G
Generic Name
Bendamustine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 27, 2022
FDA Product Classification

INGREDIENTS (3)

BENDAMUSTINE HYDROCHLORIDEActive
Quantity: 45 mg in 0.5 mL
Code: 981Y8SX18M
Classification: ACTIB
N,N-DIMETHYLACETAMIDEInactive
Code: JCV5VDB3HY
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

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