NDC 45963-640

Busulfan

Busulfan

Busulfan is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Busulfan.

Product ID45963-640_ae7a687b-9248-4971-bdf9-0c48efea7550
NDC45963-640
Product TypeHuman Prescription Drug
Proprietary NameBusulfan
Generic NameBusulfan
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-01-04
Marketing End Date2021-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA205139
Labeler NameActavis Pharma, Inc.
Substance NameBUSULFAN
Active Ingredient Strength6 mg/mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN

Packaging

NDC 45963-640-57

1 VIAL, SINGLE-DOSE in 1 CARTON (45963-640-57) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-01-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45963-640-57 [45963064057]

Busulfan INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA205139
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-01-04

NDC 45963-640-77 [45963064077]

Busulfan INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA205139
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-01-04

Drug Details

Active Ingredients

IngredientStrength
BUSULFAN6 mg/mL

OpenFDA Data

SPL SET ID:45650bfe-5f73-4591-812a-14d0feeecaad
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 253113
  • UPC Code
  • 0345963640574
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    69784-620MYLERANbusulfan
    76388-713MYLERANbusulfan
    0517-0920N/Abusulfan

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