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United States · US · US:0173-0547_568047d4-1669-4c16-bbd0-d242a6b91507

MEPRON

Orange BookUNIISPLATC P01AX06

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

Identification

ManufacturerGlaxoSmithKline LLC
CountryUS (United States)
ATC codeP01AX06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0173054700
    42 POUCH in 1 DOSE PACK (0173-0547-00) / 5 mL in 1 POUCH

Annotations

UNII (FDA Substance ID)
Y883P1Z2LT
ATOVAQUONE
RxCUI 60212
Orange Book
N020500
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": {
    "b426b6bf-f07e-4580-97ae-dfca1ddf5b8f": {
      "match": "brand_token",
      "title": "MEPRON (ATOVAQUONE) SUSPENSION [GLAXOSMITHKLINE LLC]",
      "spl_version": "27",
      "published_date": "2026-04-06"
    }
  },
  "productid": "0173-0547_568047d4-1669-4c16-bbd0-d242a6b91507",
  "productndc": "0173-0547",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "020500",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "750MG/5ML",
        "product_no": "001",
        "approval_date": "Feb 8, 1995"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATOVAQUONE",
  "proprietary_name": "MEPRON",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA020500",
  "marketing_category": "NDA",
  "nonproprietary_name": "atovaquone",
  "start_marketing_date": "19980918",
  "active_numerator_strength": "750"
}

Related drugs

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