NDC 66758-046

Fludarabine Phosphate

Fludarabine Phosphate

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

Product ID66758-046_ff9d0403-be44-469d-9dfe-d2156094bf60
NDC66758-046
Product TypeHuman Prescription Drug
Proprietary NameFludarabine Phosphate
Generic NameFludarabine Phosphate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2007-10-12
Marketing CategoryNDA / NDA
Application NumberNDA022137
Labeler NameSandoz Inc
Substance NameFLUDARABINE PHOSPHATE
Active Ingredient Strength25 mg/mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 66758-046-01

1 VIAL, SINGLE-DOSE in 1 CARTON (66758-046-01) > 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2007-10-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66758-046-01 [66758004601]

Fludarabine Phosphate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA022137
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-10-12
Marketing End Date2017-04-11

Drug Details

Active Ingredients

IngredientStrength
FLUDARABINE PHOSPHATE25 mg/mL

OpenFDA Data

SPL SET ID:1a2d4b3a-e1f7-498e-9acc-d01f3523a1d2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1740865
  • Pharmacological Class

    • 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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