NDC 76388-713

MYLERAN

Busulfan

MYLERAN is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aspen Global Inc.. The primary component is Busulfan.

Product ID76388-713_0bb7ea71-8acc-438e-ae7e-0ab3fbaa2e39
NDC76388-713
Product TypeHuman Prescription Drug
Proprietary NameMYLERAN
Generic NameBusulfan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1985-03-21
Marketing CategoryNDA / NDA
Application NumberNDA009386
Labeler NameAspen Global Inc.
Substance NameBUSULFAN
Active Ingredient Strength2 mg/1
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 76388-713-25

25 TABLET, FILM COATED in 1 BOTTLE (76388-713-25)
Marketing Start Date1985-03-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76388-713-25 [76388071325]

MYLERAN TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA009386
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1985-03-21

Drug Details

Active Ingredients

IngredientStrength
BUSULFAN2 mg/1

OpenFDA Data

SPL SET ID:bf456fc7-3a79-47f7-8acc-600b5e2f0dc2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197422
  • 105551

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    69784-620MYLERANbusulfan
    76388-713MYLERANbusulfan
    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
    59148-047BUSULFEXbusulfan
    59148-070BUSULFEXbusulfan
    0517-0920N/Abusulfan

    Trademark Results [MYLERAN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MYLERAN
    MYLERAN
    71644161 0596271 Live/Registered
    BURROUGHS WELLCOME & CO.(U. S. A.) INC.
    1953-03-25
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