NDC 42367-521

BELRAPZO

Bendamustine Hydrochloride

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

Product ID42367-521_0881d6eb-34b3-466e-a95a-25f530b24aa3
NDC42367-521
Product TypeHuman Prescription Drug
Proprietary NameBELRAPZO
Generic NameBendamustine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-06-03
Marketing CategoryNDA / NDA
Application NumberNDA205580
Labeler NameEagle Pharmaceuticals, Inc
Substance NameBENDAMUSTINE HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42367-521-25

1 VIAL, MULTI-DOSE in 1 CARTON (42367-521-25) > 1 INJECTION in 1 VIAL, MULTI-DOSE
Marketing Start Date2019-06-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42367-521-25 [42367052125]

BELRAPZO INJECTION
Marketing CategoryNDA
Application NumberNDA205580
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-03

Drug Details

Active Ingredients

IngredientStrength
BENDAMUSTINE HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:9759a4ae-82ca-40cf-9c02-e1cadb21cbdc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1726097
    • UPC Code
  • 0342367521256

    • Pharmacological Class

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

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

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

    Trademark Results [BELRAPZO]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BELRAPZO
    BELRAPZO
    87866979 5869212 Live/Registered
    Eagle Pharmaceuticals, Inc.
    2018-04-06
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