NDC 70121-1244

Busulfan

Busulfan

Busulfan is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Busulfan.

Product ID70121-1244_31fe5f81-7575-4635-84d7-aa89717adedc
NDC70121-1244
Product TypeHuman Prescription Drug
Proprietary NameBusulfan
Generic NameBusulfan
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-12-18
Marketing CategoryANDA / ANDA
Application NumberANDA209580
Labeler NameAmneal Pharmaceuticals LLC
Substance NameBUSULFAN
Active Ingredient Strength6 mg/mL
Pharm ClassesAlkylating Activity [MoA], Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70121-1244-7

8 VIAL, SINGLE-DOSE in 1 CARTON (70121-1244-7) > 10 mL in 1 VIAL, SINGLE-DOSE (70121-1244-1)
Marketing Start Date2017-12-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70121-1244-1 [70121124401]

Busulfan INJECTION
Marketing CategoryANDA
Application NumberANDA209580
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-12-18

NDC 70121-1244-7 [70121124407]

Busulfan INJECTION
Marketing CategoryANDA
Application NumberANDA209580
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-12-18

Drug Details

Active Ingredients

IngredientStrength
BUSULFAN6 mg/mL

OpenFDA Data

SPL SET ID:ac9448da-37ad-4609-9aef-eedf8be0f69c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 253113
    • UPC Code
  • 0370121124412

    • Pharmacological Class

    • 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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