icosapent ethyl

Generic: icosapent ethyl

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icosapent ethyl
Generic Name icosapent ethyl
Labeler avkare
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

icosapent ethyl 1 g/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-046
Product ID 42291-046_484c1be6-d44c-23ed-e063-6394a90acd5d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209525
Listing Expiration 2027-12-31
Marketing Start 2023-12-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291046
Hyphenated Format 42291-046

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 ANDA209525 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-046-12)
source: ndc

Packages (1)

42291-046-12 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-046-12)

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": "484c1be6-d44c-23ed-e063-6394a90acd5d", "openfda": {"unii": ["6GC8A4PAYH"], "rxcui": ["1304979"], "spl_set_id": ["0bc72bd8-1f33-b01c-e063-6394a90a77ea"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-046-12)", "package_ndc": "42291-046-12", "marketing_start_date": "20231205"}], "brand_name": "Icosapent Ethyl", "product_id": "42291-046_484c1be6-d44c-23ed-e063-6394a90acd5d", "dosage_form": "CAPSULE, LIQUID FILLED", "product_ndc": "42291-046", "generic_name": "Icosapent Ethyl", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Icosapent Ethyl", "active_ingredients": [{"name": "ICOSAPENT ETHYL", "strength": "1 g/1"}], "application_number": "ANDA209525", "marketing_category": "ANDA", "marketing_start_date": "20231205", "listing_expiration_date": "20271231"}