NDC 50383-955

Trifluridine

Trifluridine

Trifluridine is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Hi-tech Pharmacal Co., Inc.. The primary component is Trifluridine.

Product ID50383-955_74748501-4565-4eab-833f-41c7e695c23a
NDC50383-955
Product TypeHuman Prescription Drug
Proprietary NameTrifluridine
Generic NameTrifluridine
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2017-07-28
Marketing CategoryANDA / ANDA
Application NumberANDA205438
Labeler NameHi-Tech Pharmacal Co., Inc.
Substance NameTRIFLURIDINE
Active Ingredient Strength10 mg/mL
Pharm ClassesNucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC],Nucleoside Metabolic Inhibitor [EPC],Nucleic Acid Synthesis Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50383-955-07

1 BOTTLE, DROPPER in 1 CARTON (50383-955-07) > 7.5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2017-07-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-955-07 [50383095507]

Trifluridine SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA205438
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-28

Drug Details

Active Ingredients

IngredientStrength
TRIFLURIDINE10 mg/mL

OpenFDA Data

SPL SET ID:0e451c1b-28a7-4f63-9aa5-6a70626d72f1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313477
  • Pharmacological Class

    • Nucleoside Analog [EXT]
    • Nucleoside Analog Antiviral [EPC]
    • Nucleoside Metabolic Inhibitor [EPC]
    • Nucleic Acid Synthesis Inhibitors [MoA]
    • Nucleoside Analog [EXT]
    • Nucleoside Analog Antiviral [EPC]
    • Nucleoside Metabolic Inhibitor [EPC]
    • Nucleic Acid Synthesis Inhibitors [MoA]

    NDC Crossover Matching brand name "Trifluridine" or generic name "Trifluridine"

    NDCBrand NameGeneric Name
    50383-955TrifluridineTrifluridine
    61314-044Trifluridinetrifluridine
    61570-037VIROPTICtrifluridine

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