Prescription medicine
Uridine triacetate Brand names: Xuriden, Vistogard
Uridine triacetate (Vistogard) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the uridine triacetate FDA label on DailyMed (effective March 31, 2026, BTG International Inc); the NDA 208169 record on Drugs@FDA; every uridine triacetate label on DailyMed.
Highlights of the record
FDA label of March 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVISTOGARD ® is indicated for the emergency treatment of adult and pediatric patients: following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours followi
Forms and strengths
- 951 mg/g
Granule.
On the market
- Earliest approval on file
- September 4, 2015 Xuriden, Btg Intl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 17, 2027 Vistogard granule; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 139 through July 30, 2026
What is uridine triacetate used for?
From the label: indications and usageVISTOGARD ® is indicated for the emergency treatment of adult and pediatric patients: following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration. […]
FDA pharmacologic class: Pyrimidine Analog.
Source: FDA drug label (VISTOGARD), NDA208159 (Btg Intl), as published by BTG International Inc, effective March 31, 2026 (SPL set 269f7363-63ed-444e-85f1-f0009e44818b), via openFDA; the full label on DailyMed
Is there a generic for uridine triacetate (Vistogard)?
No generic uridine triacetate is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Vistogard granule, the last expiring on August 17, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2027 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for uridine triacetate?
The FDA Adverse Event Reporting System holds 139 reports that list uridine triacetate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 27 are coded as a death and 32 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?
- Uridine triacetate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other