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United States · US · US:0078-0568_d8b344bc-882f-4f60-8593-8c6ed1a11919
COARTEM
Orange BookUNIISPLATC P01BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeP01BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11007805684524 TABLET in 1 BOTTLE (0078-0568-45)
Annotations
UNII (FDA Substance ID)
C7D6T3H22J
ARTEMETHER
RxCUI 18343
Orange Book
N022268
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "C7D6T3H22J",
"rxcui": "18343",
"inchikey": "SXYIRMFQILZOAM-HVNFFKDJSA-N",
"display_name": "ARTEMETHER",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"7866ec19-dfac-47d4-a53f-511a12643cbf": {
"match": "brand_token",
"title": "COARTEM (ARTEMETHER AND LUMEFANTRINE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "25",
"published_date": "2026-03-30"
}
},
"productid": "0078-0568_d8b344bc-882f-4f60-8593-8c6ed1a11919",
"productndc": "0078-0568",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "022268",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "20MG;120MG",
"product_no": "001",
"approval_date": "Apr 7, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARTEMETHER; LUMEFANTRINE",
"proprietary_name": "COARTEM",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA022268",
"marketing_category": "NDA",
"nonproprietary_name": "artemether and lumefantrine",
"start_marketing_date": "20090407",
"active_numerator_strength": "20; 120"
}Related drugs
Other records sharing ATC code P01BE.
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