NDC 63459-348

Bendeka

Bendamustine Hydrochloride

Bendeka is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Bendamustine Hydrochloride.

Product ID63459-348_01ec2935-0653-4173-8e90-b3e3dbb135a6
NDC63459-348
Product TypeHuman Prescription Drug
Proprietary NameBendeka
Generic NameBendamustine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-12-08
Marketing CategoryNDA / NDA
Application NumberNDA208194
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameBENDAMUSTINE HYDROCHLORIDE
Active Ingredient Strength25 mg/mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 63459-348-04

1 VIAL, MULTI-DOSE in 1 CARTON (63459-348-04) > 4 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2015-12-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63459-348-04 [63459034804]

Bendeka INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208194
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-12-08

Drug Details

Active Ingredients

IngredientStrength
BENDAMUSTINE HYDROCHLORIDE25 mg/mL

OpenFDA Data

SPL SET ID:ace9a43b-f9bd-4896-abfe-0ef4fec67ddf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1726102
  • 1726097
    • UPC Code
  • 0363459348049

    • Pharmacological Class

    • Alkylating Activity [MoA]
    • Alkylating Drug [EPC]

    NDC Crossover Matching brand name "Bendeka" or generic name "Bendamustine Hydrochloride"

    NDCBrand NameGeneric Name
    63459-348Bendekabendamustine hydrochloride
    42367-521BELRAPZObendamustine hydrochloride
    10019-079BENDAMUSTINE HYDROCHLORIDEbendamustine hydrochloride
    16729-250bendamustine hydrochloridebendamustine hydrochloride
    16729-251bendamustine hydrochloridebendamustine hydrochloride
    42367-520BENDAMUSTINE HYDROCHLORIDEbendamustine hydrochloride
    63459-390TREANDABendamustine Hydrochloride
    63459-391TREANDABendamustine Hydrochloride
    71225-120VIVIMUSTABENDAMUSTINE HYDROCHLORIDE

    Trademark Results [Bendeka]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BENDEKA
    BENDEKA
    86611898 4938294 Live/Registered
    Cephalon, Inc.
    2015-04-28
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