icosapent ethyl

Generic: icosapent ethyl

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icosapent ethyl
Generic Name icosapent ethyl
Labeler epic pharma, llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

icosapent ethyl .5 g/1

Manufacturer
EPIC PHARMA, LLC

Identifiers & Regulatory

Product NDC 42806-559
Product ID 42806-559_b5b1117d-99ab-43b3-af28-cae2626df281
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217919
Listing Expiration 2026-12-31
Marketing Start 2023-12-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806559
Hyphenated Format 42806-559

Supplemental Identifiers

RxCUI
1304979 1811180
UNII
6GC8A4PAYH

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name icosapent ethyl (source: ndc)
Generic Name icosapent ethyl (source: ndc)
Application Number ANDA217919 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 g/1
source: ndc
Packaging
  • 240 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-559-24)
source: ndc

Packages (1)

Ingredients (1)

icosapent ethyl (.5 g/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "b5b1117d-99ab-43b3-af28-cae2626df281", "openfda": {"unii": ["6GC8A4PAYH"], "rxcui": ["1304979", "1811180"], "spl_set_id": ["6db749b9-c817-41cd-909f-dd60a90c9f73"], "manufacturer_name": ["EPIC PHARMA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-559-24)", "package_ndc": "42806-559-24", "marketing_start_date": "20231222"}], "brand_name": "ICOSAPENT ETHYL", "product_id": "42806-559_b5b1117d-99ab-43b3-af28-cae2626df281", "dosage_form": "CAPSULE, LIQUID FILLED", "product_ndc": "42806-559", "generic_name": "icosapent ethyl", "labeler_name": "EPIC PHARMA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ICOSAPENT ETHYL", "active_ingredients": [{"name": "ICOSAPENT ETHYL", "strength": ".5 g/1"}], "application_number": "ANDA217919", "marketing_category": "ANDA", "marketing_start_date": "20231222", "listing_expiration_date": "20261231"}