NDC 63323-192

Fludarabine

Fludarabine Phosphate

Fludarabine is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Fludarabine Phosphate.

Product ID63323-192_40c40275-b5a2-4682-9c89-f92f55bb05fb
NDC63323-192
Product TypeHuman Prescription Drug
Proprietary NameFludarabine
Generic NameFludarabine Phosphate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2007-11-16
Marketing CategoryANDA / ANDA
Application NumberANDA078393
Labeler NameFresenius Kabi USA, LLC
Substance NameFLUDARABINE PHOSPHATE
Active Ingredient Strength25 mg/mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-192-02

1 VIAL in 1 BOX (63323-192-02) > 2 mL in 1 VIAL
Marketing Start Date2007-11-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-192-02 [63323019202]

Fludarabine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078393
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-11-16

Drug Details

Active Ingredients

IngredientStrength
FLUDARABINE PHOSPHATE25 mg/mL

OpenFDA Data

SPL SET ID:cf5255cc-91fd-4132-973b-764dba142eae
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" or generic name "Fludarabine Phosphate"

    NDCBrand NameGeneric Name
    63323-192FludarabineFLUDARABINE PHOSPHATE
    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

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