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United States · US · US:68001-245_51afabde-910b-096f-e063-6394a90ac5bb

Atovaquone and Proguanil Hydrochloride

Orange BookUNIISPLATC P01AX

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

Identification

ManufacturerBluePoint Laboratories
CountryUS (United States)
ATC codeP01AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6800124500
    100 TABLET, FILM COATED in 1 BOTTLE (68001-245-00)
  • ndc11
    6800124515
    2 BLISTER PACK in 1 CARTON (68001-245-15) / 12 TABLET, FILM COATED in 1 BLISTER PACK (68001-245-14)

Annotations

UNII (FDA Substance ID)
Y883P1Z2LT
ATOVAQUONE
RxCUI 60212
Orange Book
A091211
ABAB
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": "68001-245_51afabde-910b-096f-e063-6394a90ac5bb",
  "productndc": "68001-245",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091211",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG;100MG",
        "product_no": "001",
        "approval_date": "Jan 12, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "62.5MG;25MG",
        "product_no": "002",
        "approval_date": "Apr 6, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATOVAQUONE; PROGUANIL HYDROCHLORIDE",
  "proprietary_name": "Atovaquone and Proguanil Hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA091211",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atovaquone and Proguanil Hydrochloride",
  "start_marketing_date": "20140313",
  "active_numerator_strength": "250; 100"
}

Related drugs

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