Omega-3-acid Ethyl Esters Capsule
NDC Package 72998-850-12

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

Package Information

Omega-3-acid Ethyl Esters capsules is omega-3-acid ethyl esters is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG). This formulation utilizes a capsule delivery system. Marketed by Kd Pharma Usa, Inc., this product is identified by NDC 72998-850 and is authorized under FDA application ANDA212504.

Identification & Billing

NDC Package Code
72998-850-12
Package Description
120 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
72998-850
11-Digit Billing Format
72998085012
RxNorm Crosswalk
  • RxCUI: 577208 - omega-3 acid ethyl esters 1 GM Oral Capsule
  • RxCUI: 577208 - omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule
  • RxCUI: 577208 - omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule

Clinical Specifications

Proprietary Name
Omega-3-acid Ethyl Esters
Non-Proprietary Name
Omega-3-acid Ethyl Esters
Substance Name
Omega-3-acid Ethyl Esters
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OMEGA-3-ACID ETHYL ESTERS 1 g/1
Pharmacologic Class
Usage Information
Omega-3-acid ethyl esters is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG).

Regulatory & Marketing

Labeler Name
Kd Pharma Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212504
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2021
Listing Expiration
12-31-2026
Exclude Flag
N
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 72998-850-12 identifies a specific commercial package of 120 capsule in 1 bottle, plastic of Omega-3-acid Ethyl Esters, a human prescription drug labeled by Kd Pharma Usa, Inc.. This capsule is formulated for oral use and contains omega-3-acid ethyl esters as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Kd Pharma Usa, Inc. on May 01, 2021. The current certification is valid through December 31, 2026.

How is this Kd Pharma Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72998085012. 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 (5-3-2)
72998-850-12
11-Digit CMS (5-4-2)
72998-0850-12

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