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  5. NDC Package Code: 61112-001-01 Omtryg

NDC Package 61112-001-01 Omtryg

View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
61112-001-01
Package Description:
120 CAPSULE in 1 BOTTLE
Product Code:
61112-001
Proprietary Name:
Omtryg
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.
11-Digit NDC Billing Format:
61112000101
NDC to RxNorm Crosswalk:
  • RxCUI: 1539373 - omega-3 acid ethyl esters 1.2 GM Oral Capsule
  • RxCUI: 1539373 - omega-3 acid ethyl esters (USP) 1200 MG Oral Capsule
  • RxCUI: 1539691 - Omtryg 1.2 GM Oral Capsule
  • RxCUI: 1539691 - omega-3 acid ethyl esters (USP) 1200 MG Oral Capsule [Omtryg]
  • RxCUI: 1539691 - Omtryg 1200 MG Oral Capsule
    • Labeler Name:
    Trygg Pharma Inc
    Sample Package:
    No
    Start Marketing Date:
    07-01-2016
    Listing Expiration Date:
    12-31-2017
    Exclude Flag:
    I
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 61112-001-01?

    The NDC Packaged Code 61112-001-01 is assigned to a package of 120 capsule in 1 bottle of Omtryg, labeled by Trygg Pharma Inc. The product's dosage form is and is administered via form.

    Is NDC 61112-001 included in the NDC Directory?

    No, Omtryg with product code 61112-001 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Trygg Pharma Inc on July 01, 2016 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 61112-001-01?

    The 11-digit format is 61112000101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-261112-001-015-4-261112-0001-01