icosapent ethyl

Generic: icosapent ethyl

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icosapent ethyl
Generic Name icosapent ethyl
Labeler hikma pharmaceuticals usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

icosapent ethyl .5 g/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0621
Product ID 0054-0621_2417e4be-d579-4c3d-8ec0-a42dc51aabf5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209457
Listing Expiration 2026-12-31
Marketing Start 2020-11-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540621
Hyphenated Format 0054-0621

Supplemental Identifiers

RxCUI
1304979 1811180
UPC
0300540621278 0300540508234
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 ANDA209457 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 g/1
source: ndc
Packaging
  • 240 CAPSULE in 1 BOTTLE (0054-0621-27)
source: ndc

Packages (1)

0054-0621-27 240 CAPSULE in 1 BOTTLE (0054-0621-27)

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": "2417e4be-d579-4c3d-8ec0-a42dc51aabf5", "openfda": {"upc": ["0300540621278", "0300540508234"], "unii": ["6GC8A4PAYH"], "rxcui": ["1304979", "1811180"], "spl_set_id": ["e3d38d1d-fbe7-413d-849a-675e7dfa9b0a"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 CAPSULE in 1 BOTTLE (0054-0621-27)", "package_ndc": "0054-0621-27", "marketing_start_date": "20230309"}], "brand_name": "Icosapent Ethyl", "product_id": "0054-0621_2417e4be-d579-4c3d-8ec0-a42dc51aabf5", "dosage_form": "CAPSULE", "product_ndc": "0054-0621", "generic_name": "Icosapent Ethyl", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Icosapent Ethyl", "active_ingredients": [{"name": "ICOSAPENT ETHYL", "strength": ".5 g/1"}], "application_number": "ANDA209457", "marketing_category": "ANDA", "marketing_start_date": "20201104", "listing_expiration_date": "20261231"}