FDA.reportPublic FDA data

fexinidazole 600 MG Tablet 10-Day Dose Pack (35 KG+)

RxCUI
2564152
RxNorm name
fexinidazole 600 MG Tablet 10-Day Dose Pack (35 KG+)
Display name
fexinidazole 600 MG Tablet 10-Day Dose Pack (35 KG+)
Full name
fexinidazole 600 MG Tablet 10-Day Dose Pack (35 KG+)
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

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
FexinidazoleFEXINIDAZOLESanofi-Aventis U.S. LLC74a611bc-9977-46bb-b626-0370b30316282025-05-02Warnings, Adverse reactionsExact identifier
rxcui: 2564152

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
74a611bc-9977-46bb-b626-0370b3031628fexinidazole 600 MG Tablet 10-Day Dose Pack (35 KG+)SY10These highlights do not include all the information needed to use FEXINIDAZOLE TABLETS safely and effectively. See full prescribing information for FEXINIDAZOLE TABLETS. FEXINIDAZOLE tablets, for oral use Initial U.S. Approval: 202120250502
74a611bc-9977-46bb-b626-0370b3031628{24 (fexinidazole 600 MG Oral Tablet) } PackGPCK10These highlights do not include all the information needed to use FEXINIDAZOLE TABLETS safely and effectively. See full prescribing information for FEXINIDAZOLE TABLETS. FEXINIDAZOLE tablets, for oral use Initial U.S. Approval: 202120250502
74a611bc-9977-46bb-b626-0370b3031628fexinidazole 600 MG Tablet 10-Day Dose Pack (35 KG+)PSN10These highlights do not include all the information needed to use FEXINIDAZOLE TABLETS safely and effectively. See full prescribing information for FEXINIDAZOLE TABLETS. FEXINIDAZOLE tablets, for oral use Initial U.S. Approval: 202120250502