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United States · US · US:67184-0582_324fd508-befc-404a-8f75-97b35d2df694
Icosapent Ethyl
In shortageOrange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerQilu Pharmaceutical Co., Ltd.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116718405821120 CAPSULE in 1 BOTTLE (67184-0582-1)
Annotations
UNII (FDA Substance ID)
6GC8A4PAYH
ICOSAPENT ETHYL
RxCUI 1304974
Orange Book
A218899
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Icosapent Ethyl Capsule
Raw payload (JSON)
{
"unii": {
"unii": "6GC8A4PAYH",
"rxcui": "1304974",
"inchikey": "SSQPWTVBQMWLSZ-AAQCHOMXSA-N",
"display_name": "ICOSAPENT ETHYL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1a50bc22-bbdf-4ba8-b162-0e12f3e9d160": {
"match": "brand_token",
"title": "ICOSAPENT ETHYL CAPSULE [STRIDES PHARMA SCIENCE LIMITED]",
"spl_version": "3",
"published_date": "2026-05-22"
}
},
"productid": "67184-0582_324fd508-befc-404a-8f75-97b35d2df694",
"productndc": "67184-0582",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "218899",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1GM",
"product_no": "001",
"approval_date": "Nov 20, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ICOSAPENT ETHYL",
"shortage_reason": "Icosapent Ethyl Capsule",
"shortage_status": "current",
"proprietary_name": "Icosapent Ethyl",
"active_ingred_unit": "g/1",
"application_number": "ANDA218899",
"marketing_category": "ANDA",
"nonproprietary_name": "Icosapent Ethyl",
"start_marketing_date": "20250101",
"active_numerator_strength": "1"
}Access this data programmatically
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