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United States · US · US:0173-0676_39349dbb-ccca-45a2-bc2b-8bd69602d7b8
MALARONE
Orange BookUNIISPLATC P01AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlaxoSmithKline LLC
CountryUS (United States)
ATC codeP01AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110173067601100 TABLET, FILM COATED in 1 BOTTLE (0173-0676-01)
Annotations
UNII (FDA Substance ID)
Y883P1Z2LT
ATOVAQUONE
RxCUI 60212
Orange Book
N021078
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Y883P1Z2LT",
"rxcui": "60212",
"inchikey": "KUCQYCKVKVOKAY-CTYIDZIISA-N",
"display_name": "ATOVAQUONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"fc22e8d8-3bfb-4f70-a599-dd81262a4887": {
"match": "brand_token",
"title": "MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]",
"spl_version": "30",
"published_date": "2026-04-06"
}
},
"productid": "0173-0676_39349dbb-ccca-45a2-bc2b-8bd69602d7b8",
"productndc": "0173-0676",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "021078",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "250MG;100MG",
"product_no": "001",
"approval_date": "Jul 14, 2000"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "62.5MG;25MG",
"product_no": "002",
"approval_date": "Jul 14, 2000"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ATOVAQUONE; PROGUANIL HYDROCHLORIDE",
"proprietary_name": "MALARONE",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA021078",
"marketing_category": "NDA",
"nonproprietary_name": "atovaquone and proguanil hydrochloride",
"start_marketing_date": "20000726",
"active_numerator_strength": "62.5; 25"
}Related drugs
Other records sharing ATC code P01AX.
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- 🇺🇸Atovaquone and Proguanil HydrochlorideMylan Pharmaceuticals Inc.
- 🇺🇸Atovaquone and Proguanil HydrochlorideProficient Rx LP
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