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United States · US · US:66993-060_9e28a4ce-4524-4921-902c-7cc939eea6b5

Atovaquone and Proguanil HCl

Orange BookUNIISPLATC P01AX

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

Identification

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

Packs · 2

  • ndc11
    6699306002
    100 TABLET, FILM COATED in 1 BOTTLE (66993-060-02)
  • ndc11
    6699306027
    24 TABLET, FILM COATED in 1 DOSE PACK (66993-060-27)

Annotations

UNII (FDA Substance ID)
Y883P1Z2LT
ATOVAQUONE
RxCUI 60212
Orange Book
N021078
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": "66993-060_9e28a4ce-4524-4921-902c-7cc939eea6b5",
  "productndc": "66993-060",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021078",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "250MG;100MG",
        "product_no": "001",
        "approval_date": "Jul 14, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "62.5MG;25MG",
        "product_no": "002",
        "approval_date": "Jul 14, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATOVAQUONE; PROGUANIL HYDROCHLORIDE",
  "proprietary_name": "Atovaquone and Proguanil HCl",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021078",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "atovaquone and proguanil hydrochloride",
  "start_marketing_date": "20120727",
  "active_numerator_strength": "250; 100"
}

Related drugs

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