Omega-3-acid Ethyl Esters Capsule, Liquid Filled
NDC Package 65162-034-06

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

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Omega-3-acid Ethyl Esters capsules is uSP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG). This formulation utilizes a capsule, liquid filled delivery system. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 65162-034 and is authorized under FDA application ANDA204940.

Identification & Billing

NDC Package Code
65162-034-06
Package Description
60 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code
65162-034
11-Digit Billing Format
65162003406
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, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
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 capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG). Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with omega-3-acid ethyl esters capsules, USP. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules, USP. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy. Limitations of Use:The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA204940
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-30-2015
End Marketing Date
07-01-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65162-034). Click a package code to view its specific billing and regulatory data.

65162-034-16
120 CAPSULE, LIQUID FILLED in 1 BOTTLE
65162-034-32
360 CAPSULE, LIQUID FILLED in 1 BOTTLE

* 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 65162-034-06 identifies a specific commercial package of 60 capsule, liquid filled in 1 bottle of Omega-3-acid Ethyl Esters, a human prescription drug labeled by Amneal Pharmaceuticals Llc. This capsule, liquid filled 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 Amneal Pharmaceuticals Llc on November 30, 2015.

How is this Amneal Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65162003406. 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)
65162-034-06
11-Digit CMS (5-4-2)
65162-0034-06

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