NDC 69452-175 Omega-3-acid Ethyl Ester

Omega-3-acid Ethyl Esters

NDC Product Code 69452-175

NDC 69452-175-17

Package Description: 60 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC 69452-175-22

Package Description: 120 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC Product Information

Omega-3-acid Ethyl Ester with NDC 69452-175 is a a human prescription drug product labeled by Bionpharma Inc.. The generic name of Omega-3-acid Ethyl Ester is omega-3-acid ethyl esters. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Bionpharma Inc.

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.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Omega-3-acid Ethyl Ester Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OMEGA-3-ACID ETHYL ESTERS 900 mg/1

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Fatty Acids -
  • Omega-3 - [CS]
  • Omega-3 Fatty Acid - [EPC] (Established Pharmacologic Class)

Product Labeler Information

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

Labeler Name: Bionpharma Inc.
Labeler Code: 69452
FDA Application Number: ANDA206455 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-15-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

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Information for Patients

Omega-3 Fatty Acids

Omega-3 Fatty Acids is pronounced as (oh may' ga)

Why is omega-3 fatty acids medication prescribed?
Omega-3 fatty acids are used together with lifestyle changes (diet, weight-loss, exercise) to reduce the amount of triglycerides (a fat-like substance) in the blood in pe...
[Read More]

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