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United States · US · US:63187-879_feeccc5c-a98f-4de7-b664-d450f77ee462

Atovaquone and Proguanil Hydrochloride

Orange BookUNIISPLATC P01AX

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeP01AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6318787916
    16 TABLET, FILM COATED in 1 BOTTLE (63187-879-16)
  • ndc11
    6318787924
    24 TABLET, FILM COATED in 1 BOTTLE (63187-879-24)

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": "63187-879_feeccc5c-a98f-4de7-b664-d450f77ee462",
  "productndc": "63187-879",
  "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": "20110818",
  "active_numerator_strength": "250; 100"
}

Related drugs

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