FDA.reportPublic FDA data

baloxavir marboxil 30 MG Granules for Oral Suspension [Xofluza]

RxCUI
2716800
RxNorm name
baloxavir marboxil 30 MG Granules for Oral Suspension [Xofluza]
Display name
baloxavir marboxil 30 MG Granules for Oral Suspension [Xofluza]
Full name
baloxavir marboxil 30 MG Granules for Oral Suspension [Xofluza]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:25

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
XofluzaBALOXAVIR MARBOXILGenentech, Inc.e49e1a61-1b7c-4be5-ac84-af6240b511e72025-12-15Warnings, Adverse reactionsExact identifier
rxcui: 2716800

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
e49e1a61-1b7c-4be5-ac84-af6240b511e7Xofluza 30 MG Granules for Oral Suspension [PSN] · baloxavir marboxil 30 MG Granules for Oral Suspension [Xofluza] [SBD] · Xofluza 30 MG Granules for Oral Suspension [SY]330These highlights do not include all the information needed to use XOFLUZA safely and effectively. See full prescribing information for XOFLUZA. XOFLUZA ® (baloxavir marboxil) tablets, for oral use XOFLUZA ® (baloxavir marboxil) for oral suspension Initial U.S. Approval: 201820251215