🇺🇸
United States · US · US:68001-245_51afabde-910b-096f-e063-6394a90ac5bb
Atovaquone and Proguanil Hydrochloride
Orange BookUNIISPLATC P01AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBluePoint Laboratories
CountryUS (United States)
ATC codeP01AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116800124500100 TABLET, FILM COATED in 1 BOTTLE (68001-245-00)
- ndc1168001245152 BLISTER PACK in 1 CARTON (68001-245-15) / 12 TABLET, FILM COATED in 1 BLISTER PACK (68001-245-14)
Annotations
UNII (FDA Substance ID)
Y883P1Z2LT
ATOVAQUONE
RxCUI 60212
Orange Book
A091211
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": "68001-245_51afabde-910b-096f-e063-6394a90ac5bb",
"productndc": "68001-245",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "091211",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG;100MG",
"product_no": "001",
"approval_date": "Jan 12, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "62.5MG;25MG",
"product_no": "002",
"approval_date": "Apr 6, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ATOVAQUONE; PROGUANIL HYDROCHLORIDE",
"proprietary_name": "Atovaquone and Proguanil Hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA091211",
"marketing_category": "ANDA",
"nonproprietary_name": "Atovaquone and Proguanil Hydrochloride",
"start_marketing_date": "20140313",
"active_numerator_strength": "250; 100"
}Related drugs
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