NDC 71288-109

Cytarabine

Cytarabine

Cytarabine is a Intrathecal; Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Meitheal Pharmaceuticals Inc.. The primary component is Cytarabine.

Product ID71288-109_1f74972a-b1fc-420b-8448-c81315df389d
NDC71288-109
Product TypeHuman Prescription Drug
Proprietary NameCytarabine
Generic NameCytarabine
Dosage FormInjection, Solution
Route of AdministrationINTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2018-07-17
Marketing CategoryANDA / ANDA
Application NumberANDA205696
Labeler NameMeitheal Pharmaceuticals Inc.
Substance NameCYTARABINE
Active Ingredient Strength2 g/20mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 71288-109-20

1 VIAL, SINGLE-DOSE in 1 CARTON (71288-109-20) > 20 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-07-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71288-109-20 [71288010920]

Cytarabine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205696
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-09-01

Drug Details

Active Ingredients

IngredientStrength
CYTARABINE2 g/20mL

OpenFDA Data

SPL SET ID:8105e590-fc7e-45b7-9604-c2d0d1be5eac
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 249364
  • Pharmacological Class

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