FDA.reportPublic FDA data

difluprednate 0.5 MG/ML Ophthalmic Suspension [Durezol]

RxCUI
804547
RxNorm name
difluprednate 0.5 MG/ML Ophthalmic Suspension [Durezol]
Display name
difluprednate 0.5 MG/ML Ophthalmic Suspension [Durezol]
Full name
difluprednate 0.5 MG/ML Ophthalmic Suspension [Durezol]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:26

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DUREZOLDIFLUPREDNATESandoz Incea520a27-f569-4b31-8bad-a25ad54b2caa2026-08-18Warnings, Adverse reactionsExact identifier
rxcui: 804547

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ea520a27-f569-4b31-8bad-a25ad54b2caaDUREZOL 0.05 % Ophthalmic Emulsion [PSN] · difluprednate 0.5 MG/ML Ophthalmic Suspension [Durezol] [SBD] · DUREZOL 0.05 % Ophthalmic Emulsion [SY] · Durezol 0.05 % Ophthalmic Suspension [SY] · Durezol 0.5 MG/ML Ophthalmic Suspension [SY]54These highlights do not include all the information needed to use DUREZOL safely and effectively. See full prescribing information for DUREZOL. DUREZOL ® (difluprednate ophthalmic emulsion) 0.05%, for topical ophthalmic use Initial U.S. Approval: 200820251024