icosapent ethyl

Generic: icosapent ethyl

Labeler: apotex corp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icosapent ethyl
Generic Name icosapent ethyl
Labeler apotex corp
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

icosapent ethyl 1 g/1

Manufacturer
Apotex Corp

Identifiers & Regulatory

Product NDC 60505-4033
Product ID 60505-4033_35fe2e84-55e5-9f20-803b-b6fd31c6773d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209437
Listing Expiration 2026-12-31
Marketing Start 2021-12-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605054033
Hyphenated Format 60505-4033

Supplemental Identifiers

RxCUI
1304979
UPC
0360505403318
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 ANDA209437 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 120 CAPSULE in 1 BOTTLE (60505-4033-1)
source: ndc

Packages (1)

60505-4033-1 120 CAPSULE in 1 BOTTLE (60505-4033-1)

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": "35fe2e84-55e5-9f20-803b-b6fd31c6773d", "openfda": {"upc": ["0360505403318"], "unii": ["6GC8A4PAYH"], "rxcui": ["1304979"], "spl_set_id": ["886aa8d8-b293-258f-b16d-be40418787a8"], "manufacturer_name": ["Apotex Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE in 1 BOTTLE (60505-4033-1)", "package_ndc": "60505-4033-1", "marketing_start_date": "20211216"}], "brand_name": "Icosapent Ethyl", "product_id": "60505-4033_35fe2e84-55e5-9f20-803b-b6fd31c6773d", "dosage_form": "CAPSULE", "product_ndc": "60505-4033", "generic_name": "Icosapent Ethyl", "labeler_name": "Apotex Corp", "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_start_date": "20211216", "listing_expiration_date": "20261231"}