warnings
WARNINGS: The recommended dosage and frequency of administration should not be exceeded (See DOSAGE AND ADMINISTRATION ).
Trifluridine
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
- Trifluridine
- Generic name
- TRIFLURIDINE
- Manufacturer
- Sandoz Inc
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- abc1d07f-91ee-4421-bc9b-457d0ed41f4c
- SPL ID
- d0e32882-06fe-4062-adae-3751ffc9979f
- Version
- 6
- Effective date
- 2024-08-01
- Source export date
- 2026-09-28
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:24:45
| Harmonized routes |
|---|
| OPHTHALMIC |
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 | ANDA | 074311 | derived:openfda.application_number |
| application number | ANDA074311 | openfda.application_number | |
| brand name | Trifluridine | openfda.brand_name | |
| generic name | TRIFLURIDINE | openfda.generic_name | |
| manufacturer name | Sandoz Inc | openfda.manufacturer_name | |
| ndc | package | 61314-044-75 | openfda.package_ndc |
| ndc | product | 61314-044 | openfda.product_ndc |
| ndc11 | package | 61314004475 | derived:openfda.package_ndc |
| rxcui | 313477 | openfda.rxcui | |
| spl id | d0e32882-06fe-4062-adae-3751ffc9979f | id | |
| spl set id | abc1d07f-91ee-4421-bc9b-457d0ed41f4c | set_id | |
| unii | RMW9V5RW38 | 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
ADVERSE REACTIONS: The most frequent adverse reactions reported during controlled clinical trials were mild, transient burning or stinging upon instillation (4.6%) and palpebral edema (2.8%). Other adverse reactions in decreasing order of reported frequency were superficial punctate keratopathy, epithelial keratopathy, hypersensitivity reaction, stromal edema, irritation, keratitis sicca, hyperemia, and increased intraocular pressure.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.