icosapent ethyl

Generic: icosapent ethyl

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

Drug Facts

Product Profile

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

icosapent ethyl .5 g/1

Manufacturer
XLCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72865-289
Product ID 72865-289_fc2e665c-7b0e-4969-998e-be05e0e73520
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216811
Listing Expiration 2026-12-31
Marketing Start 2024-02-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72865289
Hyphenated Format 72865-289

Supplemental Identifiers

RxCUI
1304979 1811180
UPC
0372865290125 0372865289242
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
  • .5 g/1
source: ndc
Packaging
  • 240 CAPSULE in 1 BOTTLE (72865-289-24)
source: ndc

Packages (1)

72865-289-24 240 CAPSULE in 1 BOTTLE (72865-289-24)

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": "fc2e665c-7b0e-4969-998e-be05e0e73520", "openfda": {"upc": ["0372865290125", "0372865289242"], "unii": ["6GC8A4PAYH"], "rxcui": ["1304979", "1811180"], "spl_set_id": ["019cc0ac-0c2f-426d-996a-6d932f954443"], "manufacturer_name": ["XLCare Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 CAPSULE in 1 BOTTLE (72865-289-24)", "package_ndc": "72865-289-24", "marketing_start_date": "20240216"}], "brand_name": "ICOSAPENT ETHYL", "product_id": "72865-289_fc2e665c-7b0e-4969-998e-be05e0e73520", "dosage_form": "CAPSULE", "product_ndc": "72865-289", "generic_name": "Icosapent ethyl", "labeler_name": "XLCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ICOSAPENT ETHYL", "active_ingredients": [{"name": "ICOSAPENT ETHYL", "strength": ".5 g/1"}], "application_number": "ANDA216811", "marketing_category": "ANDA", "marketing_start_date": "20240216", "listing_expiration_date": "20261231"}