Atovaquone and Proguanil Hydrochloride

Orange BookUNIISPLATC P01AX

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeP01AX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378416201
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4162-01)

Annotations

UNII (FDA Substance ID)

Y883P1Z2LT

ATOVAQUONE

RxCUI 60212

Orange Book

A202362

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": "0378-4162_bcbdccd4-74df-4499-9d98-2e95c958c7f6",
  "productndc": "0378-4162",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202362",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "62.5MG;25MG",
        "product_no": "001",
        "approval_date": "May 27, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG;100MG",
        "product_no": "002",
        "approval_date": "May 27, 2014"
      }
    ],
    "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": "ANDA202362",
  "marketing_category": "ANDA",
  "nonproprietary_name": "atovaquone and proguanil hydrochloride",
  "start_marketing_date": "20140528",
  "active_numerator_strength": "250; 100"
}

Related drugs

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