1. Home
  2. Labeler Index
  3. Rebel Distributors Corp
  4. NDC Product Code: 21695-795 Lovaza

NDC 21695-795 Lovaza

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 21695-795?
  5. Lovaza 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:
21695-795
Proprietary Name:
Lovaza
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Rebel Distributors Corp
Labeler Code:
21695
Product Label ID:
7892fb39-94c6-41cc-b8cd-d9d145180a96
Start Marketing Date: [9]
10-21-2008
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - LIGHT YELLOW)
Shape:
CAPSULE (C48336)
Size(s):
24 MM
Imprint(s):
LOVAZA
Score:
1

Code Structure Chart

Product Details

What is NDC 21695-795?

The NDC code 21695-795 is assigned by the FDA to the product Lovaza which is product labeled by Rebel Distributors Corp. The product's dosage form is . The product is distributed in a single package with assigned NDC code 21695-795-72 120 capsule, liquid filled 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 Lovaza?

Omega-3 acid ethyl esters, a type of fat found in fish oil, is used along with diet and exercise to help lower levels of a certain blood fat (triglyceride). It may also raise "good" cholesterol (HDL). In general, this drug is used after your blood fat levels have not been fully controlled by non-drug treatments (such as diet changes, exercise, decreasing alcohol intake, weight loss if overweight, controlling blood sugar if diabetic, and regulating your thyroid hormone levels). Lowering triglycerides and increasing "good" cholesterol may help decrease the risk for strokes and heart attacks. Omega-3 acid ethyl esters are thought to work by decreasing the amount of triglyceride the body makes.

Which are Lovaza UNII Codes?

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

  • OMEGA-3-ACID ETHYL ESTERS (UNII: D87YGH4Z0Q)
  • OMEGA-3-ACID ETHYL ESTERS (UNII: D87YGH4Z0Q) (Active Moiety)

Which are Lovaza 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 Lovaza?

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:
  • RxCUI: 577208 - omega-3 acid ethyl esters 1 GM Oral Capsule
  • RxCUI: 577208 - omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule
  • RxCUI: 577208 - omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule
  • RxCUI: 607044 - Lovaza 1 GM Oral Capsule
  • RxCUI: 607044 - omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule [Lovaza]

* 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".