icosapent ethyl

Generic: icosapent ethyl

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

Drug Facts

Product Profile

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

icosapent ethyl 500 mg/1

Manufacturer
Dr. Reddy's Laboratories, Inc.

Identifiers & Regulatory

Product NDC 43598-746
Product ID 43598-746_c23214a0-3fde-a1b2-d1ed-e7f120af949a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209499
Listing Expiration 2026-12-31
Marketing Start 2023-04-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598746
Hyphenated Format 43598-746

Supplemental Identifiers

RxCUI
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 ANDA209499 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 240 CAPSULE in 1 BOTTLE (43598-746-72)
source: ndc

Packages (1)

43598-746-72 240 CAPSULE in 1 BOTTLE (43598-746-72)

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": "c23214a0-3fde-a1b2-d1ed-e7f120af949a", "openfda": {"unii": ["6GC8A4PAYH"], "rxcui": ["1811180"], "spl_set_id": ["cdcee03e-5df1-a8fc-7490-dfdc624ce6d6"], "manufacturer_name": ["Dr. Reddy's Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 CAPSULE in 1 BOTTLE (43598-746-72)", "package_ndc": "43598-746-72", "marketing_start_date": "20230417"}], "brand_name": "Icosapent Ethyl", "product_id": "43598-746_c23214a0-3fde-a1b2-d1ed-e7f120af949a", "dosage_form": "CAPSULE", "product_ndc": "43598-746", "generic_name": "Icosapent Ethyl", "labeler_name": "Dr. Reddy's Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Icosapent Ethyl", "active_ingredients": [{"name": "ICOSAPENT ETHYL", "strength": "500 mg/1"}], "application_number": "ANDA209499", "marketing_category": "ANDA", "marketing_start_date": "20230417", "listing_expiration_date": "20261231"}