🇺🇸
United States · US · US:68462-402_a6232b89-d1c0-4114-879d-6c9320a92eb2
Atovaquone and Proguanil Hydrochloride Pediatric
Orange BookUNIISPLATC P01AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc.,USA
CountryUS (United States)
ATC codeP01AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116846240201100 TABLET, FILM COATED in 1 BOTTLE (68462-402-01)
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": "68462-402_a6232b89-d1c0-4114-879d-6c9320a92eb2",
"productndc": "68462-402",
"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 Pediatric",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA091211",
"marketing_category": "ANDA",
"nonproprietary_name": "Atovaquone and Proguanil Hydrochloride Pediatric",
"start_marketing_date": "20150408",
"active_numerator_strength": "62.5; 25"
}Related drugs
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- 🇺🇸Atovaquone and Proguanil HydrochlorideGlenmark Pharmaceuticals Inc.,USA
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