NDC 45963-621

Fludarabine phosphate

Fludarabine Phosphate

Fludarabine phosphate is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Fludarabine Phosphate.

Product ID45963-621_e0dcd67d-bac1-44b3-ab5f-5c539c00afea
NDC45963-621
Product TypeHuman Prescription Drug
Proprietary NameFludarabine phosphate
Generic NameFludarabine Phosphate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-03-02
Marketing CategoryANDA / ANDA
Application NumberANDA203738
Labeler NameActavis Pharma, Inc.
Substance NameFLUDARABINE PHOSPHATE
Active Ingredient Strength25 mg/mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 45963-621-51

1 VIAL, SINGLE-DOSE in 1 CARTON (45963-621-51) > 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2017-03-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45963-621-51 [45963062151]

Fludarabine phosphate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA203738
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-03-02

Drug Details

Active Ingredients

IngredientStrength
FLUDARABINE PHOSPHATE25 mg/mL

OpenFDA Data

SPL SET ID:a7743c62-2230-4289-92dc-6fc9c61f41d2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1740865
  • 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 "Fludarabine phosphate" or generic name "Fludarabine Phosphate"

    NDCBrand NameGeneric Name
    16729-131FLUDARABINE PHOSPHATEFLUDARABINE
    24201-237fludarabine phosphatefludarabine phosphate
    25021-237fludarabine phosphatefludarabine phosphate
    25021-242Fludarabine PhosphateFludarabine Phosphate
    45963-609Fludarabine phosphateFludarabine phosphate
    45963-621Fludarabine phosphateFludarabine phosphate
    59923-604Fludarabine PhosphateFludarabine Phosphate
    61703-344Fludarabine PhosphateFLUDARABINE PHOSPHATE
    66758-046Fludarabine PhosphateFludarabine Phosphate
    63323-192FludarabineFLUDARABINE PHOSPHATE

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