icosapent ethyl

Generic: icosapent ethyl

Labeler: qilu pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icosapent ethyl
Generic Name icosapent ethyl
Labeler qilu pharmaceutical co., ltd.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

icosapent ethyl 1 g/1

Manufacturer
Qilu Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 67184-0582
Product ID 67184-0582_324fd508-befc-404a-8f75-97b35d2df694
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218899
Listing Expiration 2026-12-31
Marketing Start 2025-01-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 671840582
Hyphenated Format 67184-0582

Supplemental Identifiers

RxCUI
1304979
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 ANDA218899 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 120 CAPSULE in 1 BOTTLE (67184-0582-1)
source: ndc

Packages (1)

67184-0582-1 120 CAPSULE in 1 BOTTLE (67184-0582-1)

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": "324fd508-befc-404a-8f75-97b35d2df694", "openfda": {"unii": ["6GC8A4PAYH"], "rxcui": ["1304979"], "spl_set_id": ["20686acb-66c5-4d75-9684-7474436e8bef"], "manufacturer_name": ["Qilu Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE in 1 BOTTLE (67184-0582-1)", "package_ndc": "67184-0582-1", "marketing_start_date": "20250101"}], "brand_name": "Icosapent Ethyl", "product_id": "67184-0582_324fd508-befc-404a-8f75-97b35d2df694", "dosage_form": "CAPSULE", "product_ndc": "67184-0582", "generic_name": "Icosapent Ethyl", "labeler_name": "Qilu Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Icosapent Ethyl", "active_ingredients": [{"name": "ICOSAPENT ETHYL", "strength": "1 g/1"}], "application_number": "ANDA218899", "marketing_category": "ANDA", "marketing_start_date": "20250101", "listing_expiration_date": "20261231"}