Lovaza
NDC Package 69784-420-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Lovaza is 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). Marketed by Woodward Pharma Services Llc, this product is identified by NDC 69784-420 and is authorized under FDA application ANDA204940.

Identification & Billing

NDC Package Code
69784-420-60
Package Description
60 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code
69784-420
11-Digit Billing Format
69784042060

Clinical Specifications

Proprietary Name
Lovaza
Dosage Form
-
Usage Information
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.

Regulatory & Marketing

Labeler Name
Woodward Pharma Services Llc
FDA Application #
ANDA204940
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-30-2015
End Marketing Date
03-31-2025
Listing Expiration
03-31-2025
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69784-420). Click a package code to view its specific billing and regulatory data.

69784-420-12
120 CAPSULE, LIQUID FILLED in 1 BOTTLE
69784-420-36
360 CAPSULE, LIQUID FILLED in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69784-420-60 identifies a specific commercial package of 60 capsule, liquid filled in 1 bottle of Lovaza, labeled by Woodward Pharma Services Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Woodward Pharma Services Llc on November 30, 2015. The current certification is valid through March 31, 2025.

What are the primary indications for this medication?

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.

How is this Woodward Pharma Services Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69784042060. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
69784-420-60
11-Digit CMS (5-4-2)
69784-0420-60

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.