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United States · US · US:68999-528_430808cb-6a2f-94ee-e063-6394a90ab6fd

Atovaquone

Orange BookUNIISPLATC P01AX06

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

Identification

ManufacturerChartwell Governmental & Specialty RX, LLC.
CountryUS (United States)
ATC codeP01AX06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6899952824
    2 TRAY in 1 BOX (68999-528-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-528-45)

Annotations

UNII (FDA Substance ID)
Y883P1Z2LT
ATOVAQUONE
RxCUI 60212
Orange Book
A207833
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": "68999-528_430808cb-6a2f-94ee-e063-6394a90ab6fd",
  "productndc": "68999-528",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "207833",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG/5ML",
        "product_no": "001",
        "approval_date": "Apr 28, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATOVAQUONE",
  "proprietary_name": "Atovaquone",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA207833",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atovaquone",
  "start_marketing_date": "20170428",
  "active_numerator_strength": "750"
}

Related drugs

Other records sharing ATC code P01AX06.

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