🇺🇸
United States · US · US:66993-060_9e28a4ce-4524-4921-902c-7cc939eea6b5
Atovaquone and Proguanil HCl
Orange BookUNIISPLATC P01AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPrasco Laboratories
CountryUS (United States)
ATC codeP01AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116699306002100 TABLET, FILM COATED in 1 BOTTLE (66993-060-02)
- ndc11669930602724 TABLET, FILM COATED in 1 DOSE PACK (66993-060-27)
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": {
"ad25ab65-42aa-48f6-b5ed-247f3685d5bf": {
"match": "brand_token",
"title": "ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES]",
"spl_version": "8",
"published_date": "2026-05-29"
}
},
"productid": "66993-060_9e28a4ce-4524-4921-902c-7cc939eea6b5",
"productndc": "66993-060",
"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": "Atovaquone and Proguanil HCl",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA021078",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "atovaquone and proguanil hydrochloride",
"start_marketing_date": "20120727",
"active_numerator_strength": "250; 100"
}Related drugs
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