NDC 59923-604

Fludarabine Phosphate

Fludarabine Phosphate

Fludarabine Phosphate is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Areva Pharmaceuticals. The primary component is Fludarabine Phosphate.

Product ID59923-604_80b3deb0-e638-9867-e053-2a91aa0a2100
NDC59923-604
Product TypeHuman Prescription Drug
Proprietary NameFludarabine Phosphate
Generic NameFludarabine Phosphate
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-12-31
Marketing CategoryANDA / ANDA
Application NumberANDA090724
Labeler NameAreva Pharmaceuticals
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 59923-604-02

1 VIAL, SINGLE-DOSE in 1 CARTON (59923-604-02) > 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59923-604-02 [59923060402]

Fludarabine Phosphate INJECTION
Marketing CategoryANDA
Application NumberANDA090724
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
FLUDARABINE PHOSPHATE25 mg/mL

OpenFDA Data

SPL SET ID:8039c2e3-ffe5-3997-e053-2991aa0ad9d0
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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