icosapent ethyl

Generic: icosapent ethyl

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icosapent ethyl
Generic Name icosapent ethyl
Labeler teva pharmaceuticals, inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

icosapent ethyl 500 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-0126
Product ID 0480-0126_0d2afdd4-3333-47dc-9653-0b63e478b36d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209525
Listing Expiration 2026-12-31
Marketing Start 2022-09-09

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04800126
Hyphenated Format 0480-0126

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 ANDA209525 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 240 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-0126-49)
source: ndc

Packages (1)

0480-0126-49 240 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-0126-49)

Ingredients (1)

icosapent ethyl (500 mg/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": "0d2afdd4-3333-47dc-9653-0b63e478b36d", "openfda": {"unii": ["6GC8A4PAYH"], "rxcui": ["1304979", "1811180"], "spl_set_id": ["de7049ae-d1d6-4267-a93b-dd5039c50c2c"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-0126-49)", "package_ndc": "0480-0126-49", "marketing_start_date": "20220909"}], "brand_name": "Icosapent Ethyl", "product_id": "0480-0126_0d2afdd4-3333-47dc-9653-0b63e478b36d", "dosage_form": "CAPSULE, LIQUID FILLED", "product_ndc": "0480-0126", "generic_name": "Icosapent Ethyl", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Icosapent Ethyl", "active_ingredients": [{"name": "ICOSAPENT ETHYL", "strength": "500 mg/1"}], "application_number": "ANDA209525", "marketing_category": "ANDA", "marketing_start_date": "20220909", "listing_expiration_date": "20261231"}