icosapent ethyl

Generic: icosapent ethyl

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

Drug Facts

Product Profile

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

icosapent ethyl .5 g/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1738
Product ID 70710-1738_b292c3ea-8ce0-471f-8c44-57d1c4df9bf5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217656
Listing Expiration 2026-12-31
Marketing Start 2023-08-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101738
Hyphenated Format 70710-1738

Supplemental Identifiers

RxCUI
1304979 1811180
UPC
0370710159276
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 (70710-1738-4)
source: ndc

Packages (1)

70710-1738-4 240 CAPSULE in 1 BOTTLE (70710-1738-4)

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": "b292c3ea-8ce0-471f-8c44-57d1c4df9bf5", "openfda": {"upc": ["0370710159276"], "unii": ["6GC8A4PAYH"], "rxcui": ["1304979", "1811180"], "spl_set_id": ["5910742b-c5e6-4029-9a19-97669e3808bc"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 CAPSULE in 1 BOTTLE (70710-1738-4)", "package_ndc": "70710-1738-4", "marketing_start_date": "20230804"}], "brand_name": "icosapent ethyl", "product_id": "70710-1738_b292c3ea-8ce0-471f-8c44-57d1c4df9bf5", "dosage_form": "CAPSULE", "product_ndc": "70710-1738", "generic_name": "icosapent ethyl", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "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": "20230804", "listing_expiration_date": "20261231"}