NDC 25021-241

Busulfan

Busulfan

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

Product ID25021-241_66e85aab-ee57-4bb0-aaaf-fe34a246a340
NDC25021-241
Product TypeHuman Prescription Drug
Proprietary NameBusulfan
Generic NameBusulfan
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-05-15
Marketing CategoryANDA / ANDA
Application NumberANDA207050
Labeler NameSagent Pharmaceuticals
Substance NameBUSULFAN
Active Ingredient Strength6 mg/mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 25021-241-10

8 VIAL in 1 CARTON (25021-241-10) > 10 mL in 1 VIAL
Marketing Start Date2017-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 25021-241-10 [25021024110]

Busulfan INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA207050
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-05-15

Drug Details

Active Ingredients

IngredientStrength
BUSULFAN6 mg/mL

OpenFDA Data

SPL SET ID:086a715e-4958-4bb5-9ebd-86171e6b6203
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 253113
  • 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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