NDC 72485-210

Busulfan

Busulfan

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

Product ID72485-210_ae29e15b-df07-403f-8d07-f99e3ce501e7
NDC72485-210
Product TypeHuman Prescription Drug
Proprietary NameBusulfan
Generic NameBusulfan
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA210931
Labeler NameArmas Pharmaceuticals Inc.
Substance NameBUSULFAN
Active Ingredient Strength6 mg/mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72485-210-08

8 VIAL, SINGLE-DOSE in 1 CARTON (72485-210-08) > 10 mL in 1 VIAL, SINGLE-DOSE (72485-210-01)
Marketing Start Date2019-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72485-210-01 [72485021001]

Busulfan INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210931
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-01

NDC 72485-210-08 [72485021008]

Busulfan INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210931
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-01

Drug Details

Active Ingredients

IngredientStrength
BUSULFAN6 mg/mL

OpenFDA Data

SPL SET ID:4049d57f-342e-4233-8292-fed6b8f128ec
Manufacturer
UNII
UPC Code
  • 0372485210015
  • 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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