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United States · US · US:81033-105_4a2e2cbc-ee5c-94ed-e063-6294a90aef55

Atovaquone Oral Suspension

Orange BookUNIISPLATC P01AX06

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerKesin Pharma Corporation
CountryUS (United States)
ATC codeP01AX06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8103310522
    20 CUP, UNIT-DOSE in 1 CARTON (81033-105-22) / 5 mL in 1 CUP, UNIT-DOSE (81033-105-05)
  • ndc11
    8103310542
    42 CUP, UNIT-DOSE in 1 CARTON (81033-105-42) / 5 mL in 1 CUP, UNIT-DOSE (81033-105-05)

Annotations

UNII (FDA Substance ID)
Y883P1Z2LT
ATOVAQUONE
RxCUI 60212
Orange Book
A210510
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": "81033-105_4a2e2cbc-ee5c-94ed-e063-6294a90aef55",
  "productndc": "81033-105",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "210510",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG/5ML",
        "product_no": "001",
        "approval_date": "May 31, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATOVAQUONE",
  "proprietary_name": "Atovaquone Oral Suspension",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA210510",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atovaquone",
  "start_marketing_date": "20260206",
  "active_numerator_strength": "750"
}

Related drugs

Other records sharing ATC code P01AX06.

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