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United States · US · US:60687-534_415fac59-7480-cad1-e063-6394a90ad7ba

Atovaquone

Orange BookUNIISPLATC P01AX06

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

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeP01AX06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6068753436
    2 TRAY in 1 CASE (60687-534-36) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-534-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-534-40)
  • ndc11
    6068753478
    7 TRAY in 1 CASE (60687-534-78) / 6 CUP, UNIT-DOSE in 1 TRAY (60687-534-52) / 5 mL in 1 CUP, UNIT-DOSE (60687-534-40)

Annotations

UNII (FDA Substance ID)
Y883P1Z2LT
ATOVAQUONE
RxCUI 60212
Orange Book
A210692
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": "60687-534_415fac59-7480-cad1-e063-6394a90ad7ba",
  "productndc": "60687-534",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "210692",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG/5ML",
        "product_no": "001",
        "approval_date": "Oct 11, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATOVAQUONE",
  "proprietary_name": "Atovaquone",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA210692",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atovaquone",
  "start_marketing_date": "20201021",
  "active_numerator_strength": "750"
}

Related drugs

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