icosapent ethyl

Generic: icosapent ethyl

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icosapent ethyl
Generic Name icosapent ethyl
Labeler amneal pharmaceuticals llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

icosapent ethyl 1 g/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 69238-2598
Product ID 69238-2598_9e7d9563-10a7-4c29-bf92-6086c3ba0ae9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217844
Listing Expiration 2026-12-31
Marketing Start 2023-11-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692382598
Hyphenated Format 69238-2598

Supplemental Identifiers

RxCUI
1304979 1811180
UPC
0369238259773 0369238259889
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 ANDA217844 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 120 CAPSULE in 1 BOTTLE (69238-2598-8)
source: ndc

Packages (1)

69238-2598-8 120 CAPSULE in 1 BOTTLE (69238-2598-8)

Ingredients (1)

icosapent ethyl (1 g/1)

Linked Drug Pages (1)

Icosapent ethyl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9e7d9563-10a7-4c29-bf92-6086c3ba0ae9", "openfda": {"upc": ["0369238259773", "0369238259889"], "unii": ["6GC8A4PAYH"], "rxcui": ["1304979", "1811180"], "spl_set_id": ["fd2b5373-1ddd-46c0-a579-d5a4f289d79f"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE in 1 BOTTLE (69238-2598-8)", "package_ndc": "69238-2598-8", "marketing_start_date": "20231101"}], "brand_name": "Icosapent ethyl", "product_id": "69238-2598_9e7d9563-10a7-4c29-bf92-6086c3ba0ae9", "dosage_form": "CAPSULE", "product_ndc": "69238-2598", "generic_name": "Icosapent ethyl", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Icosapent ethyl", "active_ingredients": [{"name": "ICOSAPENT ETHYL", "strength": "1 g/1"}], "application_number": "ANDA217844", "marketing_category": "ANDA", "marketing_start_date": "20231101", "listing_expiration_date": "20261231"}