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United States · US · US:65162-693_ea283214-c6a9-42be-a5fe-b35a74aa56af
ATOVAQUONE
Orange BookUNIISPLATC P01AX06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeP01AX06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165162693881 BOTTLE in 1 CARTON (65162-693-88) / 210 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
Y883P1Z2LT
ATOVAQUONE
RxCUI 60212
Orange Book
A202960
AB
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": "65162-693_ea283214-c6a9-42be-a5fe-b35a74aa56af",
"productndc": "65162-693",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "202960",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG/5ML",
"product_no": "001",
"approval_date": "Mar 18, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ATOVAQUONE",
"proprietary_name": "ATOVAQUONE",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA202960",
"marketing_category": "ANDA",
"nonproprietary_name": "ATOVAQUONE",
"start_marketing_date": "20110209",
"active_numerator_strength": "750"
}Related drugs
Other records sharing ATC code P01AX06.
- DKAtovaquon "Nordic Prime"Nordic Prime ApS
- NLAtovaquon Glenmark 750 mg/5 ml suspensie voor oraal gebruikGlenmark Arzneimittel GmbH
- 🇺🇸atovaquoneGlenmark Pharmaceuticals Inc., USA
- 🇺🇸AtovaquoneA2A Integrated Pharmaceuticals, LLC
- 🇺🇸AtovaquoneLohxa
- 🇺🇸AtovaquoneKesin Pharma
- 🇺🇸AtovaquoneNorthStar RxLLC
- 🇺🇸AtovaquonePAI Holdings, LLC dba PAI Pharma
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