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 ID: 50383-955_74748501-4565-4eab-833f-41c7e695c23a
• NDC: 50383-955
• Product Type: Human Prescription Drug
• Proprietary Name: Trifluridine
• Generic Name: Trifluridine
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2017-07-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205438
• Labeler Name: Hi-Tech Pharmacal Co., Inc.
• Substance Name: TRIFLURIDINE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC],Nucleoside Metabolic Inhibitor [EPC],Nucleic Acid Synthesis Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 50383-955-07

1 BOTTLE, DROPPER in 1 CARTON (50383-955-07) > 7.5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2017-07-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50383-955-07 [50383095507]

Trifluridine SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA205438
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-07-28

Drug Details

Active Ingredients

Ingredient	Strength
TRIFLURIDINE	10 mg/mL

OpenFDA Data

• SPL SET ID: 0e451c1b-28a7-4f63-9aa5-6a70626d72f1
• Manufacturer:
  • Hi-Tech Pharmacal Co., Inc.
• UNII:
  • RMW9V5RW38
• 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"

NDC	Brand Name	Generic Name
50383-955	Trifluridine	Trifluridine
61314-044	Trifluridine	trifluridine
61570-037	VIROPTIC	trifluridine