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United States · US · US:15054-0080_614b2fb1-3b17-49e1-a63d-869acaafa72e
IQIRVO
Orange BookUNIISPLATC A05AX06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIpsen Biopharmaceuticals, Inc.
CountryUS (United States)
ATC codeA05AX06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1115054008011 BOTTLE in 1 CARTON (15054-0080-1) / 30 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
2J3H5C81A5
ELAFIBRANOR
Orange Book
N218860
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2J3H5C81A5",
"rxcui": null,
"inchikey": "AFLFKFHDSCQHOL-IZZDOVSWSA-N",
"display_name": "ELAFIBRANOR",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d78aa14f-6ec1-4b1d-a4ae-e48658137a25": {
"match": "brand_token",
"title": "IQIRVO (ELAFIBRANOR) TABLET, FILM COATED [IPSEN BIOPHARMACEUTICALS, INC.]",
"spl_version": "3",
"published_date": "2024-06-13"
}
},
"productid": "15054-0080_614b2fb1-3b17-49e1-a63d-869acaafa72e",
"productndc": "15054-0080",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "218860",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "80MG",
"product_no": "001",
"approval_date": "Jun 10, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ELAFIBRANOR",
"proprietary_name": "IQIRVO",
"active_ingred_unit": "mg/1",
"application_number": "NDA218860",
"marketing_category": "NDA",
"nonproprietary_name": "elafibranor",
"start_marketing_date": "20240610",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code A05AX06.
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