icosapent ethyl

Generic: icosapent ethyl

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icosapent ethyl
Generic Name icosapent ethyl
Labeler camber pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

icosapent ethyl .5 g/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-298
Product ID 31722-298_2a0df4fe-0c84-4b88-8aee-902cb8c82af5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216811
Listing Expiration 2026-12-31
Marketing Start 2024-02-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722298
Hyphenated Format 31722-298

Supplemental Identifiers

RxCUI
1304979 1811180
UPC
0331722299121 0331722298247
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 ANDA216811 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 g/1
source: ndc
Packaging
  • 240 CAPSULE in 1 BOTTLE (31722-298-24)
source: ndc

Packages (1)

31722-298-24 240 CAPSULE in 1 BOTTLE (31722-298-24)

Ingredients (1)

icosapent ethyl (.5 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": "2a0df4fe-0c84-4b88-8aee-902cb8c82af5", "openfda": {"upc": ["0331722299121", "0331722298247"], "unii": ["6GC8A4PAYH"], "rxcui": ["1304979", "1811180"], "spl_set_id": ["3e3498ab-f35e-4597-8556-89bf9fdd1406"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 CAPSULE in 1 BOTTLE (31722-298-24)", "package_ndc": "31722-298-24", "marketing_start_date": "20240216"}], "brand_name": "ICOSAPENT ETHYL", "product_id": "31722-298_2a0df4fe-0c84-4b88-8aee-902cb8c82af5", "dosage_form": "CAPSULE", "product_ndc": "31722-298", "generic_name": "Icosapent ethyl", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ICOSAPENT ETHYL", "active_ingredients": [{"name": "ICOSAPENT ETHYL", "strength": ".5 g/1"}], "application_number": "ANDA216811", "marketing_category": "ANDA", "marketing_start_date": "20240216", "listing_expiration_date": "20261231"}