icosapent ethyl

In shortageOrange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSoftgel Healthcare Private Limited

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3591617381
240 CAPSULE in 1 BOTTLE (35916-1738-1)

Annotations

UNII (FDA Substance ID)

6GC8A4PAYH

ICOSAPENT ETHYL

RxCUI 1304974

Orange Book

A217656

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": {
    "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": "35916-1738_51ab40c9-9b15-4fa3-a355-6ac5d36552ee",
  "productndc": "35916-1738",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "217656",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Apr 20, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "002",
        "approval_date": "Apr 20, 2023"
      }
    ],
    "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": "ANDA217656",
  "marketing_category": "ANDA",
  "nonproprietary_name": "icosapent ethyl",
  "start_marketing_date": "20250301",
  "active_numerator_strength": ".5"
}

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