NDC 16729-351

Busulfan

Busulfan

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

Product ID16729-351_8e670ad6-c930-3559-e053-2995a90a3d0f
NDC16729-351
Product TypeHuman Prescription Drug
Proprietary NameBusulfan
Generic NameBusulfan
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-07-22
Marketing CategoryANDA / ANDA
Application NumberANDA210148
Labeler NameAccord Healthcare, 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 16729-351-92

8 VIAL, SINGLE-DOSE in 1 CARTON (16729-351-92) > 10 mL in 1 VIAL, SINGLE-DOSE (16729-351-03)
Marketing Start Date2019-07-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16729-351-03 [16729035103]

Busulfan INJECTION
Marketing CategoryANDA
Application NumberANDA210148
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-22

NDC 16729-351-92 [16729035192]

Busulfan INJECTION
Marketing CategoryANDA
Application NumberANDA210148
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-22

Drug Details

Active Ingredients

IngredientStrength
BUSULFAN6 mg/mL

OpenFDA Data

SPL SET ID:fe0ddd44-ef02-4827-b164-7fcbb45bcc1b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 253113
  • UPC Code
  • 0316729351034
  • 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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