Icosapent Ethyl
NDC Package 35916-0958-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Icosapent Ethyl is capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to icosapent ethyl or any of its components. Marketed by Softgel Healthcare Private Limited, this product is identified by NDC 35916-0958 and is authorized under FDA application ANDA218994.

Identification & Billing

NDC Package Code
35916-0958-1
Package Description
120 g in 1 BOTTLE
Product Code
35916-0958
11-Digit Billing Format
35916095801

Clinical Specifications

Proprietary Name
Icosapent Ethyl
Dosage Form
-
Usage Information
Icosapent ethyl capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to icosapent ethyl or any of its components.

Regulatory & Marketing

Labeler Name
Softgel Healthcare Private Limited
FDA Application #
ANDA218994
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-02-2024
End Marketing Date
12-02-2024
Listing Expiration
12-02-2024
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 35916-0958-1 identifies a specific commercial package of 120 g in 1 bottle of Icosapent Ethyl, labeled by Softgel Healthcare Private Limited. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Softgel Healthcare Private Limited on December 02, 2024. The current certification is valid through December 02, 2024.

How is this Softgel Healthcare Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35916095801. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
35916-0958-1
11-Digit CMS (5-4-2)
35916-0958-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.