NDC 45963-609

Fludarabine phosphate

Fludarabine Phosphate

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

Product ID45963-609_13fec225-ce1e-4855-936d-7166a066ba9a
NDC45963-609
Product TypeHuman Prescription Drug
Proprietary NameFludarabine phosphate
Generic NameFludarabine Phosphate
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-01-05
Marketing CategoryANDA / ANDA
Application NumberANDA078610
Labeler NameActavis Pharma, Inc.
Substance NameFLUDARABINE PHOSPHATE
Active Ingredient Strength50 mg/2mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 45963-609-55

1 VIAL, GLASS in 1 CARTON (45963-609-55) > 2 mL in 1 VIAL, GLASS
Marketing Start Date2015-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45963-609-55 [45963060955]

Fludarabine phosphate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA078610
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-05

Drug Details

Active Ingredients

IngredientStrength
FLUDARABINE PHOSPHATE50 mg/2mL

OpenFDA Data

SPL SET ID:3adca34b-4f65-4e21-8058-3c01fc7fc9bb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1740864
  • UPC Code
  • 0345963609557
  • 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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