Icosapent Ethyl
NDC 35916-0958

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 35916-0958?
  5. Icosapent Ethyl Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Icosapent Ethyl is a ANDA-approved product labeled by Softgel Healthcare Private Limited. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a yellow product. This product entry covers the primary NDC 35916-0958 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
35916-0958
Proprietary Name:
Icosapent Ethyl
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Softgel Healthcare Private Limited
Labeler Code:
35916
Product Label ID:
07a8174b-f0ed-c277-e063-6394a90a9eb1
FDA Application Number: [6]
ANDA218994
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
12-02-2024
End Marketing Date: [10]
12-02-2024
Listing Expiration Date: [11]
12-02-2024
Exclude Flag: [12]
D

Product Characteristics

Color(s):
YELLOW (C48330 - (AMBER))
Shape:
CAPSULE (C48336)
Size(s):
25 MM
Imprint(s):
0958
Score:
1

Code Structure Chart

Product Details

What is NDC 35916-0958?

The NDC code 35916-0958 is assigned by the FDA to the product Icosapent Ethyl. This pharmaceutical product is labeled by Softgel Healthcare Private Limited and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 35916-0958-1. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Icosapent ethyl capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to icosapent ethyl or any of its components.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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Patient Education

Icosapent Ethyl


Icosapent ethyl is used together with lifestyle changes (diet, weight loss, exercise) to reduce the amount of triglycerides (a fat-like substance) in the blood. It is also used along with cholesterol-lowering medications (statins) to decrease the risk of a heart attack, a stroke, or other heart problems that require hospitalization in certain adults with high triglyceride levels and heart disease or diabetes with 2 or more other heart disease risk factors. Icosapent ethyl is in a class of medications called antilipemic or lipid-regulating agents. Icosapent ethyl may work by decreasing the amount of triglycerides and other fats made in the liver.
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".