NDC 0409-1112

BUSULFAN

Busulfan

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

Product ID0409-1112_1e2080b5-8c77-4eb1-95bf-4cbd86c27995
NDC0409-1112
Product TypeHuman Prescription Drug
Proprietary NameBUSULFAN
Generic NameBusulfan
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-02-28
Marketing CategoryANDA / ANDA
Application NumberANDA205672
Labeler NameHospira, Inc.
Substance NameBUSULFAN
Active Ingredient Strength6 mg/mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0409-1112-01

8 CARTON in 1 CARTON (0409-1112-01) > 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1112-10) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-1112-01 [00409111201]

BUSULFAN INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205672
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-02-28

NDC 0409-1112-10 [00409111210]

BUSULFAN INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205672
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-02-28

Drug Details

Active Ingredients

IngredientStrength
BUSULFAN6 mg/mL

OpenFDA Data

SPL SET ID:b9c7f0dc-988d-466e-8031-400ec4f60f21
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 253113
  • 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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