Lovaza Capsule
NDC Package 80725-420-12

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

Package Information

Lovaza (omega-3-acid ethyl esters) capsules 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). This formulation utilizes a capsule delivery system. Marketed by Waylis Therapeutics Llc, this product is identified by NDC 80725-420 and is authorized under FDA application NDA021654.

Identification & Billing

NDC Package Code
80725-420-12
Package Description
120 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
80725-420
11-Digit Billing Format
80725042012
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
120 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lovaza
Non-Proprietary Name
Omega-3-acid Ethyl Esters
Substance Name
Omega-3-acid Ethyl Esters
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OMEGA-3-ACID ETHYL ESTERS 1 g/1
Pharmacologic Class
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
Waylis Therapeutics Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021654
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-15-2025
Listing Expiration
12-31-2027
Exclude Flag
N
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 80725-420-12 identifies a specific commercial package of 120 capsule in 1 bottle, plastic of Lovaza, a human prescription drug labeled by Waylis Therapeutics Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 120 billable units per package. This capsule is formulated for oral use and contains omega-3-acid ethyl esters as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Waylis Therapeutics Llc on January 15, 2025. The current certification is valid through December 31, 2027.

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 Waylis Therapeutics Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80725042012. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 120 total billable units per package. 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)
80725-420-12
11-Digit CMS (5-4-2)
80725-0420-12

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