Omega-3-acid Ethyl Esters
NDC 65162-034
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Omega-3-acid Ethyl Esters is a ANDA-approved product labeled by Amneal Pharmaceuticals Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a yellow product. This product entry covers the primary NDC 65162-034 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
65162-034
Proprietary Name:
Omega-3-acid Ethyl Esters
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
65162
Product Label ID:
FDA Application Number: [6]
ANDA204940
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
11-30-2015
End Marketing Date: [10]
07-01-2026
Listing Expiration Date: [11]
07-01-2026
Exclude Flag: [12]
D
Product Characteristics
Color(s):
YELLOW (C48330 - CLEAR)
Shape:
CAPSULE (C48336)
Size(s):
23 MM
Imprint(s):
AN34
Score:
1
Code Structure Chart
Product Details
What is NDC 65162-034?
The NDC code 65162-034 is assigned by the FDA to the product Omega-3-acid Ethyl Esters. This pharmaceutical product is labeled by Amneal Pharmaceuticals Llc and is currently categorized as listed product. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 65162-034-06, 65162-034-16, 65162-034-32. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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.
Which are the associated 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 the Inactive Ingredients associated 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:
- GELATIN (UNII: 2G86QN327L)
- GLYCERIN (UNII: PDC6A3C0OX)
- WATER (UNII: 059QF0KO0R)
- ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
* Please review the full disclaimer at the bottom of this page.
Patient Education
Omega-3 Fatty Acids
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 people with very high triglycerides. Omega-3 fatty acids are in a class of medications called antilipemic or lipid-regulating agents. Omega-3 fatty acids may work by decreasing the amount of triglycerides and other fats made in the liver.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
