vascepa

Generic: icosapent ethyl

Labeler: amarin pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vascepa
Generic Name icosapent ethyl
Labeler amarin pharma inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

icosapent ethyl 500 mg/1

Manufacturer
Amarin Pharma Inc.

Identifiers & Regulatory

Product NDC 52937-003
Product ID 52937-003_63fca6b2-7659-402c-90f1-9e7738a7db56
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202057
Listing Expiration 2026-12-31
Marketing Start 2016-09-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52937003
Hyphenated Format 52937-003

Supplemental Identifiers

RxCUI
1304979 1304985 1811180 1811182
UPC
0352937001200 0352937005208
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 vascepa (source: ndc)
Generic Name icosapent ethyl (source: ndc)
Application Number NDA202057 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (52937-003-16) / 16 CAPSULE in 1 BLISTER PACK
  • 240 CAPSULE in 1 BOTTLE (52937-003-40)
source: ndc

Packages (2)

52937-003-16 1 BLISTER PACK in 1 CARTON (52937-003-16) / 16 CAPSULE in 1 BLISTER PACK 52937-003-40 240 CAPSULE in 1 BOTTLE (52937-003-40)

Ingredients (1)

icosapent ethyl (500 mg/1)

Linked Drug Pages (1)

Vascepa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "63fca6b2-7659-402c-90f1-9e7738a7db56", "openfda": {"upc": ["0352937001200", "0352937005208"], "unii": ["6GC8A4PAYH"], "rxcui": ["1304979", "1304985", "1811180", "1811182"], "spl_set_id": ["9c1a2828-1583-4414-ab22-a60480e8e508"], "manufacturer_name": ["Amarin Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (52937-003-16)  / 16 CAPSULE in 1 BLISTER PACK", "package_ndc": "52937-003-16", "marketing_start_date": "20160916"}, {"sample": false, "description": "240 CAPSULE in 1 BOTTLE (52937-003-40)", "package_ndc": "52937-003-40", "marketing_start_date": "20160916"}], "brand_name": "Vascepa", "product_id": "52937-003_63fca6b2-7659-402c-90f1-9e7738a7db56", "dosage_form": "CAPSULE", "product_ndc": "52937-003", "generic_name": "icosapent ethyl", "labeler_name": "Amarin Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vascepa", "active_ingredients": [{"name": "ICOSAPENT ETHYL", "strength": "500 mg/1"}], "application_number": "NDA202057", "marketing_category": "NDA", "marketing_start_date": "20160916", "listing_expiration_date": "20261231"}