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  4. NDC Product Code: 61112-001 Omtryg

NDC 61112-001 Omtryg

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 61112-001?
  5. Omtryg Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
61112-001
Proprietary Name:
Omtryg
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Trygg Pharma Inc
Labeler Code:
61112
Product Label ID:
5fe15bdb-f59f-4b87-8e5d-8a3d5683eb3d
Start Marketing Date: [9]
07-01-2016
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - LIGHT YELLOW)
Shape:
OVAL (C48345)
Size(s):
24 MM
Imprint(s):
TP0001
Score:
1

Code Structure Chart

Product Details

What is NDC 61112-001?

The NDC code 61112-001 is assigned by the FDA to the product Omtryg which is product labeled by Trygg Pharma Inc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 61112-001-01 120 capsule in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Omtryg?

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.

Which are Omtryg UNII Codes?

The UNII codes for the active ingredients in this product are:

  • OMEGA-3-ACID ETHYL ESTERS (UNII: D87YGH4Z0Q)
  • OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (Active Moiety)

Which are Omtryg Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Omtryg?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".