NDC 63323-120

Cytarabine

Cytarabine

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

Product ID63323-120_6594799a-7b02-4847-aff7-1cb7842771bd
NDC63323-120
Product TypeHuman Prescription Drug
Proprietary NameCytarabine
Generic NameCytarabine
Dosage FormInjection, Solution
Route of AdministrationINTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2004-11-29
Marketing CategoryANDA / ANDA
Application NumberANDA076512
Labeler NameFresenius Kabi USA, LLC
Substance NameCYTARABINE
Active Ingredient Strength100 mg/mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-120-20

1 VIAL, SINGLE-DOSE in 1 CARTON (63323-120-20) > 20 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2004-11-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-120-20 [63323012020]

Cytarabine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076512
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-11-29

Drug Details

Active Ingredients

IngredientStrength
CYTARABINE100 mg/mL

OpenFDA Data

SPL SET ID:c4fdc56e-efd7-4825-a518-ef430b2b3df0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 249364
  • Pharmacological Class

    • Nucleic Acid Synthesis Inhibitors [MoA]
    • Nucleoside Metabolic Inhibitor [EPC]

    NDC Crossover Matching brand name "Cytarabine" or generic name "Cytarabine"

    NDCBrand NameGeneric Name
    61703-303CYTARABINECYTARABINE
    61703-304CytarabineCYTARABINE
    61703-305CytarabineCYTARABINE
    61703-319CytarabineCYTARABINE
    63323-120CytarabineCYTARABINE
    67457-452CytarabineCytarabine
    67457-454CytarabineCytarabine
    67457-455cytarabinecytarabine
    68083-337CytarabineCytarabine
    68083-343CytarabineCytarabine
    71288-108CytarabineCytarabine
    71288-109CytarabineCytarabine
    71288-168CytarabineCytarabine
    71288-169CytarabineCytarabine

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