icosapent ethyl

Generic: icosapent ethyl

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icosapent ethyl
Generic Name icosapent ethyl
Labeler american health packaging
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

icosapent ethyl 1 g/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-764
Product ID 60687-764_47a64acc-3806-d861-e063-6394a90a8d02
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209437
Marketing Start 2024-02-21
Marketing End 2027-05-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687764
Hyphenated Format 60687-764

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 ethyl (source: ndc)
Generic Name icosapent ethyl (source: ndc)
Application Number ANDA209437 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (60687-764-21) / 1 CAPSULE in 1 BLISTER PACK (60687-764-11)
source: ndc

Packages (1)

60687-764-21 30 BLISTER PACK in 1 CARTON (60687-764-21) / 1 CAPSULE in 1 BLISTER PACK (60687-764-11)

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": "47a64acc-3806-d861-e063-6394a90a8d02", "openfda": {"unii": ["6GC8A4PAYH"], "rxcui": ["1304979"], "spl_set_id": ["fd28217d-5817-43b0-8185-7c7ec6da83f3"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (60687-764-21)  / 1 CAPSULE in 1 BLISTER PACK (60687-764-11)", "package_ndc": "60687-764-21", "marketing_end_date": "20270531", "marketing_start_date": "20240221"}], "brand_name": "Icosapent Ethyl", "product_id": "60687-764_47a64acc-3806-d861-e063-6394a90a8d02", "dosage_form": "CAPSULE", "product_ndc": "60687-764", "generic_name": "Icosapent Ethyl", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Icosapent Ethyl", "active_ingredients": [{"name": "ICOSAPENT ETHYL", "strength": "1 g/1"}], "application_number": "ANDA209437", "marketing_category": "ANDA", "marketing_end_date": "20270531", "marketing_start_date": "20240221"}