icosapent ethyl

Generic: icosapent ethyl

Labeler: vitruvias therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icosapent ethyl
Generic Name icosapent ethyl
Labeler vitruvias therapeutics, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

icosapent ethyl 1 g/1

Manufacturer
Vitruvias Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 69680-186
Product ID 69680-186_cd69c4f4-24bc-4a95-89af-8afacbed1d08
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219156
Listing Expiration 2026-12-31
Marketing Start 2025-10-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69680186
Hyphenated Format 69680-186

Supplemental Identifiers

RxCUI
1304979
UPC
0369680186924
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 ANDA219156 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 120 CAPSULE in 1 BOTTLE (69680-186-92)
source: ndc

Packages (1)

69680-186-92 120 CAPSULE in 1 BOTTLE (69680-186-92)

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": "cd69c4f4-24bc-4a95-89af-8afacbed1d08", "openfda": {"upc": ["0369680186924"], "unii": ["6GC8A4PAYH"], "rxcui": ["1304979"], "spl_set_id": ["4c3e26d6-9297-42ad-94b4-04e394155b41"], "manufacturer_name": ["Vitruvias Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE in 1 BOTTLE (69680-186-92)", "package_ndc": "69680-186-92", "marketing_start_date": "20251020"}], "brand_name": "Icosapent Ethyl", "product_id": "69680-186_cd69c4f4-24bc-4a95-89af-8afacbed1d08", "dosage_form": "CAPSULE", "product_ndc": "69680-186", "generic_name": "Icosapent Ethyl", "labeler_name": "Vitruvias Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Icosapent Ethyl", "active_ingredients": [{"name": "ICOSAPENT ETHYL", "strength": "1 g/1"}], "application_number": "ANDA219156", "marketing_category": "ANDA", "marketing_start_date": "20251020", "listing_expiration_date": "20261231"}