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United States · US · US:60505-4033_e0a75c2f-7422-2c9c-a132-3cc51dde6021
Icosapent Ethyl
In shortageOrange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116050540331120 CAPSULE in 1 BOTTLE (60505-4033-1)
Annotations
UNII (FDA Substance ID)
6GC8A4PAYH
ICOSAPENT ETHYL
RxCUI 1304974
Orange Book
A209437
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": "60505-4033_e0a75c2f-7422-2c9c-a132-3cc51dde6021",
"productndc": "60505-4033",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "209437",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1GM",
"product_no": "001",
"approval_date": "Jun 30, 2021"
}
],
"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": "ANDA209437",
"marketing_category": "ANDA",
"nonproprietary_name": "Icosapent Ethyl",
"start_marketing_date": "20211216",
"active_numerator_strength": "1"
}Access this data programmatically
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