icosapent

Generic: icosapent ethyl

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icosapent
Generic Name icosapent ethyl
Labeler bryant ranch prepack
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

icosapent ethyl 1000 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-9312
Product ID 63629-9312_8988eb81-87de-4d83-8d5a-f9e0d2863618
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 636299312
Hyphenated Format 63629-9312

Supplemental Identifiers

RxCUI
1304979
UNII
6GC8A4PAYH

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 (63629-9312-1)
source: ndc

Packages (1)

63629-9312-1 120 CAPSULE in 1 BOTTLE (63629-9312-1)

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": "8988eb81-87de-4d83-8d5a-f9e0d2863618", "openfda": {"unii": ["6GC8A4PAYH"], "rxcui": ["1304979"], "spl_set_id": ["cc28828d-beab-45cc-a3b6-151c5fee3924"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE in 1 BOTTLE (63629-9312-1)", "package_ndc": "63629-9312-1", "marketing_start_date": "20220706"}], "brand_name": "Icosapent", "product_id": "63629-9312_8988eb81-87de-4d83-8d5a-f9e0d2863618", "dosage_form": "CAPSULE", "product_ndc": "63629-9312", "generic_name": "Icosapent Ethyl", "labeler_name": "Bryant Ranch Prepack", "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"}