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United States · US · US:69452-252_4523911f-9d9c-4b0c-e063-6394a90ac76d

Atovaquone

Orange BookUNIISPLATC P01AX06

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

Identification

ManufacturerBionpharma Inc.
CountryUS (United States)
ATC codeP01AX06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6945225287
    1 BOTTLE in 1 CARTON (69452-252-87) / 210 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
Y883P1Z2LT
ATOVAQUONE
RxCUI 60212
Orange Book
A212918
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": "69452-252_4523911f-9d9c-4b0c-e063-6394a90ac76d",
  "productndc": "69452-252",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "212918",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG/5ML",
        "product_no": "001",
        "approval_date": "Mar 30, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATOVAQUONE",
  "proprietary_name": "Atovaquone",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA212918",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atovaquone",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "750"
}

Related drugs

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