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United States · US · US:0904-7459_9c1dfc30-52ac-4fec-a728-135917f39c1a

ATOVAQUONE

Orange BookUNIISPLATC P01AX06

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

Identification

ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeP01AX06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0904745925
    3 TRAY in 1 CASE (0904-7459-25) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7459-41)
  • ndc11
    0904745953
    7 TRAY in 1 CASE (0904-7459-53) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7459-41)

Annotations

UNII (FDA Substance ID)
Y883P1Z2LT
ATOVAQUONE
RxCUI 60212
Orange Book
A214272
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": "0904-7459_9c1dfc30-52ac-4fec-a728-135917f39c1a",
  "productndc": "0904-7459",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "214272",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG/5ML",
        "product_no": "001",
        "approval_date": "Oct 25, 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": "ANDA214272",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atovaquone Oral Suspension",
  "start_marketing_date": "20240708",
  "active_numerator_strength": "750"
}

Related drugs

Other records sharing ATC code P01AX06.

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