Omega-3 Acid Ethyl Esters Oil
NDC Package 85378-001-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Omega-3 Acid Ethyl Esters oils is omega-3 acid ethyl esters, a type of fat found in fish oil, is used along with diet and exercise to help lower levels of a certain blood fat (triglyceride). This formulation utilizes a oil delivery system. Marketed by Kinomega Biopharm Inc., this product is identified by NDC 85378-001.

Identification & Billing

NDC Package Code
85378-001-01
Package Description
190 kg in 1 DRUM
Product Code
85378-001
11-Digit Billing Format
85378000101

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
Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.
Active Ingredient(s)
OMEGA-3-ACID ETHYL ESTERS 1 kg/kg
Usage Information
Omega-3 acid ethyl esters, a type of fat found in fish oil, is used along with diet and exercise to help lower levels of a certain blood fat (triglyceride). It may also raise "good" cholesterol (HDL). In general, this drug is used after your blood fat levels have not been fully controlled by non-drug treatments (such as diet changes, exercise, decreasing alcohol intake, weight loss if overweight, controlling blood sugar if diabetic, and regulating your thyroid hormone levels). Lowering triglycerides and increasing "good" cholesterol may help decrease the risk for strokes and heart attacks. Omega-3 acid ethyl esters are thought to work by decreasing the amount of triglyceride the body makes.

Regulatory & Marketing

Labeler Name
Kinomega Biopharm Inc.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-14-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 85378-001-01 identifies a specific commercial package of 190 kg in 1 drum of Omega-3 Acid Ethyl Esters (UNFINISHED drug), a bulk ingredient labeled by Kinomega Biopharm Inc.. This oil is formulated for 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 Kinomega Biopharm Inc. on April 14, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Omega-3 acid ethyl esters, a type of fat found in fish oil, is used along with diet and exercise to help lower levels of a certain blood fat (triglyceride). It may also raise "good" cholesterol (HDL). In general, this drug is used after your blood fat levels have not been fully controlled by non-drug treatments (such as diet changes, exercise, decreasing alcohol intake, weight loss if overweight, controlling blood sugar if diabetic, and regulating your thyroid hormone levels). Lowering triglycerides and increasing "good" cholesterol may help decrease the risk for strokes and heart attacks. Omega-3 acid ethyl esters are thought to work by decreasing the amount of triglyceride the body makes.

How is this Kinomega Biopharm Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85378000101. 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)
85378-001-01
11-Digit CMS (5-4-2)
85378-0001-01

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