icosapent ethyl

Generic: icosapent ethyl

Labeler: softgel healthcare private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icosapent ethyl
Generic Name icosapent ethyl
Labeler softgel healthcare private limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

icosapent ethyl .5 g/1

Manufacturer
Softgel Healthcare Private Limited

Identifiers & Regulatory

Product NDC 35916-1738
Product ID 35916-1738_51ab40c9-9b15-4fa3-a355-6ac5d36552ee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217656
Listing Expiration 2026-12-31
Marketing Start 2025-03-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 359161738
Hyphenated Format 35916-1738

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 ANDA217656 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 g/1
source: ndc
Packaging
  • 240 CAPSULE in 1 BOTTLE (35916-1738-1)
source: ndc

Packages (1)

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

Ingredients (1)

icosapent ethyl (.5 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": "51ab40c9-9b15-4fa3-a355-6ac5d36552ee", "openfda": {"unii": ["6GC8A4PAYH"], "rxcui": ["1304979", "1811180"], "spl_set_id": ["6f5838cd-4d17-401d-8e2a-652d0e73c1e9"], "manufacturer_name": ["Softgel Healthcare Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 CAPSULE in 1 BOTTLE (35916-1738-1)", "package_ndc": "35916-1738-1", "marketing_start_date": "20250301"}], "brand_name": "icosapent ethyl", "product_id": "35916-1738_51ab40c9-9b15-4fa3-a355-6ac5d36552ee", "dosage_form": "CAPSULE", "product_ndc": "35916-1738", "generic_name": "icosapent ethyl", "labeler_name": "Softgel Healthcare Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "icosapent ethyl", "active_ingredients": [{"name": "ICOSAPENT ETHYL", "strength": ".5 g/1"}], "application_number": "ANDA217656", "marketing_category": "ANDA", "marketing_start_date": "20250301", "listing_expiration_date": "20261231"}