FDA.reportPublic FDA data

sonidegib 200 MG Oral Capsule [Odomzo]

RxCUI
1659927
RxNorm name
sonidegib 200 MG Oral Capsule [Odomzo]
Display name
sonidegib 200 MG Oral Capsule [Odomzo]
Full name
sonidegib 200 MG Oral Capsule [Odomzo]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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
OdomzoSONIDEGIBSun Pharmaceutical Industries, Inc.028312dc-d155-4fd5-8abd-6bb9f011d3cc2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1659927

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
028312dc-d155-4fd5-8abd-6bb9f011d3ccOdomzo 200 MG Oral Capsule [PSN] · sonidegib 200 MG Oral Capsule [Odomzo] [SBD] · Odomzo 200 MG (as sonidegib phosphate) Oral Capsule [SY]314These highlights do not include all the information needed to use ODOMZO safely and effectively. See full prescribing information for ODOMZO. ODOMZO ® (sonidegib) capsules, for oral use Initial U.S. Approval: 201520241231