warnings and cautions
5 WARNINGS AND PRECAUTIONS None
XURIDEN
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- XURIDEN
- Generic name
- URIDINE TRIACETATE
- Manufacturer
- BTG International Inc
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 88ca4d2b-3905-474b-9fd6-c81474f2fb4b
- SPL ID
- 2e671cf8-09be-ac40-e063-6294a90aaf8f
- Version
- 4
- Effective date
- 2025-02-18
- Source export date
- 2026-09-28
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:45:30
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | NDA | 208169 | derived:openfda.application_number |
| application number | NDA208169 | openfda.application_number | |
| brand name | XURIDEN | openfda.brand_name | |
| generic name | URIDINE TRIACETATE | openfda.generic_name | |
| manufacturer name | BTG International Inc | openfda.manufacturer_name | |
| ndc | package | 50633-330-02 | openfda.package_ndc |
| ndc | package | 50633-330-30 | openfda.package_ndc |
| ndc | product | 50633-330 | openfda.product_ndc |
| ndc11 | package | 50633033030 | derived:openfda.package_ndc |
| ndc11 | package | 50633033002 | derived:openfda.package_ndc |
| rxcui | 1665473 | openfda.rxcui | |
| rxcui | 1665467 | openfda.rxcui | |
| spl id | 2e671cf8-09be-ac40-e063-6294a90aaf8f | id | |
| spl set id | 88ca4d2b-3905-474b-9fd6-c81474f2fb4b | set_id | |
| unii | 2WP61F175M | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
6 ADVERSE REACTIONS No adverse reactions were reported in clinical trials with XURIDEN in patients with hereditary orotic aciduria. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact BTG International Inc. at (1-877-377-3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions and using a wide range of doses, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of XURIDEN was assessed in 4 patients with hereditary orotic aciduria ranging in age from 3 to 19 years (3 male, 1 female) who received 60 mg/kg of XURIDEN once daily for six weeks. All patients continued to receive XURIDEN for at least 24 months at dosages of up to 120 mg/kg once daily. No adverse reactions were reported with XURIDEN.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.