NDC 61314-044

Trifluridine

Trifluridine

Trifluridine is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Trifluridine.

Product ID61314-044_0db13470-fcc5-4378-86ab-20f36277ab3c
NDC61314-044
Product TypeHuman Prescription Drug
Proprietary NameTrifluridine
Generic NameTrifluridine
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2001-05-14
Marketing CategoryANDA / ANDA
Application NumberANDA074311
Labeler NameSandoz Inc
Substance NameTRIFLURIDINE
Active Ingredient Strength10 mg/mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 61314-044-75

7.5 mL in 1 BOTTLE, PLASTIC (61314-044-75)
Marketing Start Date2001-05-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61314-044-75 [61314004475]

Trifluridine SOLUTION
Marketing CategoryANDA
Application NumberANDA074311
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2001-05-14

Drug Details

Active Ingredients

IngredientStrength
TRIFLURIDINE10 mg/mL

OpenFDA Data

SPL SET ID:abc1d07f-91ee-4421-bc9b-457d0ed41f4c
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]

    Medicade Reported Pricing

    61314044710 METIPRANOLOL 0.3% EYE DROPS

    Pricing Unit: ML | Drug Type:

    61314044705 METIPRANOLOL 0.3% EYE DROPS

    Pricing Unit: ML | Drug Type:

    61314004475 TRIFLURIDINE 1% EYE DROPS

    Pricing Unit: ML | Drug Type:

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

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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.