NDC 59148-070

BUSULFEX

Busulfan

BUSULFEX is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Otsuka America Pharmaceutical, Inc.. The primary component is Busulfan.

Product ID59148-070_77fb1c39-73eb-53c7-e053-2991aa0a64f5
NDC59148-070
Product TypeHuman Prescription Drug
Proprietary NameBUSULFEX
Generic NameBusulfan
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date1999-02-04
Marketing CategoryNDA / NDA
Application NumberNDA020954
Labeler NameOtsuka America Pharmaceutical, Inc.
Substance NameBUSULFAN
Active Ingredient Strength6 mg/mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 59148-070-91

8 VIAL in 1 PACKAGE (59148-070-91) > 10 mL in 1 VIAL (59148-070-90)
Marketing Start Date1999-02-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59148-070-90 [59148007090]

BUSULFEX INJECTION
Marketing CategoryNDA
Application NumberNDA020954
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1999-02-04

NDC 59148-070-91 [59148007091]

BUSULFEX INJECTION
Marketing CategoryNDA
Application NumberNDA020954
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1999-02-04

Drug Details

Active Ingredients

IngredientStrength
BUSULFAN6 mg/mL

OpenFDA Data

SPL SET ID:5cb9d285-1803-4a99-946a-d0b239b32df6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 253113
  • 284425
  • Pharmacological Class

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

    NDC Crossover Matching brand name "BUSULFEX" or generic name "Busulfan"

    NDCBrand NameGeneric Name
    59148-047BUSULFEXbusulfan
    59148-070BUSULFEXbusulfan
    0409-1112BUSULFANBUSULFAN
    16729-351Busulfanbusulfan
    25021-241BusulfanBusulfan
    45963-640BusulfanBusulfan
    51817-170Busulfanbusulfan
    60505-6177Busulfanbusulfan
    65219-160BusulfanBusulfan
    67457-893BusulfanBusulfan
    70121-1244BusulfanBusulfan
    70860-216Busulfanbusulfan
    71288-116BusulfanBusulfan
    71288-158BusulfanBusulfan
    72485-210BusulfanBusulfan
    72606-559BusulfanBusulfan
    69784-620MYLERANbusulfan
    76388-713MYLERANbusulfan
    0517-0920N/Abusulfan

    Trademark Results [BUSULFEX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BUSULFEX
    BUSULFEX
    75252920 2254101 Live/Registered
    OTSUKA PHARMACEUTICAL CO., LTD.
    1997-03-06

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