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Molecule

Uridine triacetate

Analogs/Derivatives [Chemical/Ingredient]
Available on requestOrphanRare diseases and enzyme replacement
Presentations
2
Brands
2
Manufacturers
1
Available from stock
0

Uridine triacetate is a pyrimidine analog indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria. It is available as granules for oral use. MedsAcross supplies Uridine triacetate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Analogs/Derivatives [Chemical/Ingredient], Pyrimidine Analog, Pyrimidines [Chemical/Ingredient]
ATC classification
A16AX13 Uridine triacetate · Metabolic disease treatments, including enzyme replacement, subgroup A16A, subgroup A16AX
US FDA first approval
4 September 2015
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Granules
Identifiers
UNII 2WP61F175MRxCUI 1665222CAS 4105-38-8DrugBank DB09144Q22075857

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

XURIDEN ® is indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria. XURIDEN is a pyrimidine analog for uridine replacement indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria.

Source: US FDA prescribing information

How it works

Uridine triacetate is an acetylated form of uridine. Following oral administration, uridine triacetate is deacetylated by nonspecific esterases present throughout the body, yielding uridine in the circulation (Figure 1). Figure 1: Uridine Triacetate Conversion to Uridine XURIDEN provides uridine in the systemic circulation of patients with hereditary orotic aciduria who cannot synthesize adequate quantities of uridine due to a genetic defect in uridine nucleotide synthesis. Figure 1

Source: US FDA prescribing information

Dosing overview

Recommended Dosage: The starting dosage is 60 mg/kg once daily, the dose may be increased to120 mg/kg (not to exceed 8 grams) once daily for insufficient efficacy. See the full prescribing information for 60 mg/kg and 120 mg/kg weight-based dosing tables. Preparation and Administration. Measure the dose using either a scale accurate to at least 0.1 gram, or a graduated teaspoon, accurate to the fraction of the dose to be administered. Administer the dose with food (applesauce, pudding or yogurt) or in milk or infant formula. See full prescribing information for preparation and administration instructions.

Source: US FDA prescribing information

Side effects

No adverse reactions were reported in clinical trials with XURIDEN in patients with hereditary orotic aciduria.

Source: US FDA prescribing information

Storage

Store at controlled room temperature, 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Uridine triacetate, sorted by availability.

MedicineManufacturerRegisterAvailability
Vistogard 951 mg/g granulesOralBTG InternationalUS FDAAvailable on request
Xuriden 951 mg/g granulesOralBTG InternationalUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 4 September 2015Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Uridine triacetate available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Uridine triacetate and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Uridine triacetate have?

The catalogue lists 2 brand names for Uridine triacetate, including Vistogard, Xuriden.

Is Uridine triacetate approved by the US FDA?

Yes. The US FDA first approved Uridine triacetate on 4 September 2015, according to Drugs@FDA.

Does Uridine triacetate need cold chain shipping?

No listed presentation of Uridine triacetate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Uridine triacetate in?

Uridine triacetate is classified under ATC code A16AX13 (Uridine triacetate).

References

  1. XURIDEN prescribing information (BTG International). U.S. National Library of Medicine, DailyMed. Retrieved 18 February 2025

Request Uridine triacetate for export supply

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