Back to search
🇺🇸

United States · US · US:50090-2980_db61f577-1818-4643-8712-23db5c162ae6

Atovaquone and Proguanil HCl

Orange BookUNIISPLATC P01AX

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeP01AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    5009029800
    7 TABLET, FILM COATED in 1 BOTTLE (50090-2980-0)
  • ndc11
    5009029801
    12 TABLET, FILM COATED in 1 BOTTLE (50090-2980-1)
  • ndc11
    5009029802
    14 TABLET, FILM COATED in 1 BOTTLE (50090-2980-2)
  • ndc11
    5009029803
    16 TABLET, FILM COATED in 1 BOTTLE (50090-2980-3)
  • ndc11
    5009029804
    24 TABLET, FILM COATED in 1 BOTTLE (50090-2980-4)
  • ndc11
    5009029805
    5 TABLET, FILM COATED in 1 BOTTLE (50090-2980-5)
  • ndc11
    5009029806
    10 TABLET, FILM COATED in 1 BOTTLE (50090-2980-6)
  • ndc11
    5009029807
    100 TABLET, FILM COATED in 1 BOTTLE (50090-2980-7)
  • ndc11
    5009029808
    20 TABLET, FILM COATED in 1 BOTTLE (50090-2980-8)
  • ndc11
    5009029809
    30 TABLET, FILM COATED in 1 BOTTLE (50090-2980-9)

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": "50090-2980_db61f577-1818-4643-8712-23db5c162ae6",
  "productndc": "50090-2980",
  "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

Other records sharing ATC code P01AX.

Access this data programmatically

Query Atovaquone and Proguanil HCl and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.