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United States · US · US:68462-421_b221c446-0200-4c11-bd0c-ff9ec502bc19

atovaquone

Orange BookUNIISPLATC P01AX06

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeP01AX06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6846242121
    210 mL in 1 BOTTLE (68462-421-21)
  • ndc11
    6846242169
    42 POUCH in 1 CARTON (68462-421-69) / 5 mL in 1 POUCH

Annotations

UNII (FDA Substance ID)
Y883P1Z2LT
ATOVAQUONE
RxCUI 60212
Orange Book
A209685
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": "68462-421_b221c446-0200-4c11-bd0c-ff9ec502bc19",
  "productndc": "68462-421",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "209685",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG/5ML",
        "product_no": "001",
        "approval_date": "Nov 21, 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": "ANDA209685",
  "marketing_category": "ANDA",
  "nonproprietary_name": "atovaquone",
  "start_marketing_date": "20171231",
  "active_numerator_strength": "750"
}

Related drugs

Other records sharing ATC code P01AX06.

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