icosapent ethyl

Generic: icosapent ethyl

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icosapent ethyl
Generic Name icosapent ethyl
Labeler northstar rx llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

icosapent ethyl 1 g/1

Manufacturer
Northstar Rx LLC

Identifiers & Regulatory

Product NDC 16714-636
Product ID 16714-636_ad34781b-7624-4344-a31f-83ef471da07b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216811
Listing Expiration 2026-12-31
Marketing Start 2025-07-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714636
Hyphenated Format 16714-636

Supplemental Identifiers

RxCUI
1304979
UPC
0316714636016
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 ANDA216811 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 120 CAPSULE in 1 BOTTLE (16714-636-01)
source: ndc

Packages (1)

16714-636-01 120 CAPSULE in 1 BOTTLE (16714-636-01)

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": "ad34781b-7624-4344-a31f-83ef471da07b", "openfda": {"upc": ["0316714636016"], "unii": ["6GC8A4PAYH"], "rxcui": ["1304979"], "spl_set_id": ["b5b0b1ae-29ab-43a5-9e6d-24374d961399"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE in 1 BOTTLE (16714-636-01)", "package_ndc": "16714-636-01", "marketing_start_date": "20250701"}], "brand_name": "ICOSAPENT ETHYL", "product_id": "16714-636_ad34781b-7624-4344-a31f-83ef471da07b", "dosage_form": "CAPSULE", "product_ndc": "16714-636", "generic_name": "Icosapent ethyl", "labeler_name": "Northstar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ICOSAPENT ETHYL", "active_ingredients": [{"name": "ICOSAPENT ETHYL", "strength": "1 g/1"}], "application_number": "ANDA216811", "marketing_category": "ANDA", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}