FDA.reportPublic FDA data

Sirturo 100 MG (as bedaquiline fumarate 120.9 MG) Oral Tablet

RxCUI
1364515
RxNorm name
Sirturo 100 MG (as bedaquiline fumarate 120.9 MG) Oral Tablet
Display name
Sirturo 100 MG (as bedaquiline fumarate 120.9 MG) Oral Tablet
Full name
Sirturo 100 MG (as bedaquiline fumarate 120.9 MG) Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:48

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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
SIRTUROBEDAQUILINE FUMARATEJanssen Products, LP1534c9ae-4948-4cf4-9f66-222a99db6d0e2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1364515

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
1534c9ae-4948-4cf4-9f66-222a99db6d0eSirturo 100 MG Oral Tablet [PSN] · bedaquiline 100 MG Oral Tablet [Sirturo] [SBD] · Sirturo 100 MG (as bedaquiline fumarate 120.9 MG) Oral Tablet [SY] · Sirturo 100 MG Oral Tablet [SY]433These highlights do not include all the information needed to use SIRTURO safely and effectively. See full prescribing information for SIRTURO. SIRTURO ® (bedaquiline) tablets, for oral use Initial U.S. Approval: 201220251017