NDC 63459-390

TREANDA

Bendamustine Hydrochloride

TREANDA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Cephalon, Inc.. The primary component is Bendamustine Hydrochloride.

Product ID63459-390_3711a43c-3f0e-4954-b22f-38b45770f2b3
NDC63459-390
Product TypeHuman Prescription Drug
Proprietary NameTREANDA
Generic NameBendamustine Hydrochloride
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-01-05
Marketing CategoryNDA / NDA
Application NumberNDA022249
Labeler NameCephalon, Inc.
Substance NameBENDAMUSTINE HYDROCHLORIDE
Active Ingredient Strength25 mg/5mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63459-390-08

1 VIAL, SINGLE-DOSE in 1 CARTON (63459-390-08) > 5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2010-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63459-390-08 [63459039008]

TREANDA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA022249
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-01-05

Drug Details

Active Ingredients

IngredientStrength
BENDAMUSTINE HYDROCHLORIDE25 mg/5mL

OpenFDA Data

SPL SET ID:39d53698-57fa-7c99-fc5b-f52a55684826
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1805012
  • 1805004
  • 1805007
  • 1805011
  • 1805001
  • 1805015
  • 1805016
  • 1805009
  • Pharmacological Class

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

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

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

    Trademark Results [TREANDA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TREANDA
    TREANDA
    90615914 not registered Live/Pending
    CEPHALON, INC.
    2021-03-31
    TREANDA
    TREANDA
    78409502 3012252 Live/Registered
    CEPHALON, INC.
    2004-04-28

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