Omtryg
NDC Package 61112-001-01

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Omtryg is ™ (omega-3-acid ethyl esters) capsules, USP, is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving OMTRYG and should continue this diet during treatment with OMTRYG.Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting OMTRYG therapy. Marketed by Trygg Pharma Inc, this product is identified by NDC 61112-001 and is authorized under FDA application NDA204977.

Identification & Billing

NDC Package Code
61112-001-01
Package Description
120 CAPSULE in 1 BOTTLE
Product Code
61112-001
11-Digit Billing Format
61112000101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Omtryg
Dosage Form
-
Usage Information
OMTRYG™ (omega-3-acid ethyl esters) capsules, USP, is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving OMTRYG and should continue this diet during treatment with OMTRYG.Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting OMTRYG therapy. 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 OMTRYG on the risk for pancreatitis has not been determined. The effect of OMTRYG on cardiovascular mortality and morbidity has not been determined.

Regulatory & Marketing

Labeler Name
Trygg Pharma Inc
FDA Application #
NDA204977
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2016
Listing Expiration
12-31-2017
Exclude Flag
I
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 61112-001-01 identifies a specific commercial package of 120 capsule in 1 bottle of Omtryg, labeled by Trygg Pharma Inc. 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 Trygg Pharma Inc on July 01, 2016. The current certification is valid through December 31, 2017.

How is this Trygg Pharma Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61112000101. 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)
61112-001-01
11-Digit CMS (5-4-2)
61112-0001-01

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