NDC 65219-160

Busulfan

Busulfan

Busulfan is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Busulfan.

Product ID65219-160_959759bf-825e-0cf4-e053-2a95a90a4d41
NDC65219-160
Product TypeHuman Prescription Drug
Proprietary NameBusulfan
Generic NameBusulfan
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-11-11
Marketing CategoryANDA / ANDA
Application NumberANDA210931
Labeler NameFresenius Kabi USA, LLC
Substance NameBUSULFAN
Active Ingredient Strength6 mg/mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65219-160-10

8 CARTON in 1 CARTON (65219-160-10) > 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-160-01) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-11-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65219-160-01 [65219016001]

Busulfan INJECTION
Marketing CategoryANDA
Application NumberANDA210931
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-11-11

NDC 65219-160-10 [65219016010]

Busulfan INJECTION
Marketing CategoryANDA
Application NumberANDA210931
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-11-11

Drug Details

Active Ingredients

IngredientStrength
BUSULFAN6 mg/mL

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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