FDA.reportPublic FDA data

atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet [Malarone]

RxCUI
864679
RxNorm name
atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet [Malarone]
Display name
atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet [Malarone]
Full name
atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet [Malarone]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:29

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MALARONEATOVAQUONE AND PROGUANIL HYDROCHLORIDEGlaxoSmithKline LLCfc22e8d8-3bfb-4f70-a599-dd81262a48872026-06-10Warnings, Adverse reactionsExact identifier
rxcui: 864679

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
fc22e8d8-3bfb-4f70-a599-dd81262a4887atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet [Malarone]SBD30These highlights do not include all the information needed to use MALARONE safely and effectively. See full prescribing information for MALARONE. MALARONE (atovaquone and proguanil hydrochloride) tablets MALARONE (atovaquone and proguanil hydrochloride) pediatric tablets Initial U.S. Approval: 200020260323
fc22e8d8-3bfb-4f70-a599-dd81262a4887Malarone 250/100 (atovaquone / proguanil HCl) Oral TabletSY30These highlights do not include all the information needed to use MALARONE safely and effectively. See full prescribing information for MALARONE. MALARONE (atovaquone and proguanil hydrochloride) tablets MALARONE (atovaquone and proguanil hydrochloride) pediatric tablets Initial U.S. Approval: 200020260323
fc22e8d8-3bfb-4f70-a599-dd81262a4887MALARONE 250 MG / 100 MG Oral TabletPSN30These highlights do not include all the information needed to use MALARONE safely and effectively. See full prescribing information for MALARONE. MALARONE (atovaquone and proguanil hydrochloride) tablets MALARONE (atovaquone and proguanil hydrochloride) pediatric tablets Initial U.S. Approval: 200020260323
fc22e8d8-3bfb-4f70-a599-dd81262a4887Malarone 250/100 Oral TabletSY30These highlights do not include all the information needed to use MALARONE safely and effectively. See full prescribing information for MALARONE. MALARONE (atovaquone and proguanil hydrochloride) tablets MALARONE (atovaquone and proguanil hydrochloride) pediatric tablets Initial U.S. Approval: 200020260323