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United States · US · US:63629-8247_322776f8-84f9-4198-b95c-353e9df6c70d
Vascepa
In shortageOrange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11636298247130 CAPSULE in 1 BOTTLE (63629-8247-1)
- ndc11636298247260 CAPSULE in 1 BOTTLE (63629-8247-2)
- ndc116362982473120 CAPSULE in 1 BOTTLE (63629-8247-3)
- ndc11636298247490 CAPSULE in 1 BOTTLE (63629-8247-4)
Annotations
UNII (FDA Substance ID)
6GC8A4PAYH
ICOSAPENT ETHYL
RxCUI 1304974
Orange Book
N202057
ABAB
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": {
"d245ddab-d81b-44bd-90d7-0e4d446d9bf5": {
"match": "brand_token",
"title": "VASCEPA (ICOSAPENT ETHYL) CAPSULE [BRYANT RANCH PREPACK]",
"spl_version": "7",
"published_date": "2026-04-09"
}
},
"productid": "63629-8247_322776f8-84f9-4198-b95c-353e9df6c70d",
"productndc": "63629-8247",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "202057",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "1GM",
"product_no": "001",
"approval_date": "Jul 26, 2012"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Feb 16, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ICOSAPENT ETHYL",
"shortage_reason": "Icosapent Ethyl Capsule",
"shortage_status": "current",
"proprietary_name": "Vascepa",
"active_ingred_unit": "mg/1",
"application_number": "NDA202057",
"marketing_category": "NDA",
"nonproprietary_name": "icosapent ethyl",
"start_marketing_date": "20121001",
"active_numerator_strength": "1000"
}Access this data programmatically
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