Prescription medicine
Trifluridine First approved as Viroptic
Trifluridine (Viroptic) is a prescription medicine with an FDA approval on record since 1980. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $23.02 per mL (Trifluridine 1% eye drops) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the trifluridine FDA label on DailyMed (effective August 1, 2024, Sandoz Inc); the NDA 18299 record on Drugs@FDA; every trifluridine label on DailyMed.
Highlights of the record
FDA label of August 1, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTrifluridine Ophthalmic Solution is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2.
Forms and strengths
- 10 mg/ml
Solution.
On the market
- Earliest approval on file
- April 10, 1980 Viroptic, Monarch Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first October 6, 1995; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $23.02 per mL Trifluridine 1% eye drops
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 430 through July 30, 2026
What is trifluridine used for?
From the label: indications and usageTrifluridine Ophthalmic Solution is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2.
FDA pharmacologic class: Nucleoside Analog Antiviral and Nucleoside Metabolic Inhibitor.
Source: FDA drug label (Trifluridine), Sandoz Inc, effective August 1, 2024 (SPL set abc1d07f-91ee-4421-bc9b-457d0ed41f4c), via openFDA; the full label on DailyMed
Is there a generic for trifluridine (Viroptic)?
The FDA approved the first generic trifluridine on October 6, 1995. 2 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists trifluridine from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1980 earliest approval on file
- 1995 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for trifluridine (Viroptic)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $23.02 per mL (Trifluridine 1% eye drops), up 4% from $22.16 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Trifluridine 1% eye drops (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Trifluridine 1% eye drops | Generic | $23.02 per mL | n/a | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for trifluridine?
The FDA Adverse Event Reporting System holds 430 reports that list trifluridine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 63 are coded as a death and 109 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other nucleoside analog antivirals
- the pharmacologic class, with prices and generics
- Trifluridine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other