icosapent

Generic: icosapent ethyl

Labeler: dr. reddy's laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icosapent
Generic Name icosapent ethyl
Labeler dr. reddy's laboratories, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

icosapent ethyl 1000 mg/1

Manufacturer
Dr. Reddy's Laboratories, Inc.

Identifiers & Regulatory

Product NDC 43598-267
Product ID 43598-267_d6afc522-23f4-025c-df81-109460653b4d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209499
Listing Expiration 2026-12-31
Marketing Start 2021-06-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598267
Hyphenated Format 43598-267

Supplemental Identifiers

RxCUI
1304979
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 (source: ndc)
Generic Name icosapent ethyl (source: ndc)
Application Number ANDA209499 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 120 CAPSULE in 1 BOTTLE (43598-267-04)
source: ndc

Packages (1)

43598-267-04 120 CAPSULE in 1 BOTTLE (43598-267-04)

Ingredients (1)

icosapent ethyl (1000 mg/1)

Linked Drug Pages (1)

Icosapent ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d6afc522-23f4-025c-df81-109460653b4d", "openfda": {"unii": ["6GC8A4PAYH"], "rxcui": ["1304979"], "spl_set_id": ["1aca884c-c464-900d-ac06-33aee7118df8"], "manufacturer_name": ["Dr. Reddy's Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE in 1 BOTTLE (43598-267-04)", "package_ndc": "43598-267-04", "marketing_start_date": "20210621"}], "brand_name": "Icosapent", "product_id": "43598-267_d6afc522-23f4-025c-df81-109460653b4d", "dosage_form": "CAPSULE", "product_ndc": "43598-267", "generic_name": "Icosapent Ethyl", "labeler_name": "Dr. Reddy's Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Icosapent", "active_ingredients": [{"name": "ICOSAPENT ETHYL", "strength": "1000 mg/1"}], "application_number": "ANDA209499", "marketing_category": "ANDA", "marketing_start_date": "20210621", "listing_expiration_date": "20261231"}