Omega-3-acid Ethyl Ester Capsule, Liquid Filled
NDC Package 63629-2448-1

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

Package Information

Omega-3-acid Ethyl Ester (omega-3-acid ethyl esters) capsules is classified as a

Identification & Billing

NDC Package Code
63629-2448-1
Package Description
120 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code
63629-2448
11-Digit Billing Format
63629244801

Clinical Specifications

Proprietary Name
Omega-3-acid Ethyl Ester
Non-Proprietary Name
Omega-3-acid Ethyl Esters
Substance Name
Omega-3-acid Ethyl Esters
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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OMEGA-3-ACID ETHYL ESTERS 900 mg/1
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Bryant Ranch Prepack
Product Type
Human Prescription Drug
FDA Application #
ANDA206455
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-15-2017
Listing Expiration
12-31-2026
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 63629-2448-1 identifies a specific commercial package of 120 capsule, liquid filled in 1 bottle of Omega-3-acid Ethyl Ester, a human prescription drug labeled by Bryant Ranch Prepack. This capsule, liquid filled 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 Bryant Ranch Prepack on January 15, 2017. The current certification is valid through December 31, 2026.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63629244801. 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 (5-4-1)
63629-2448-1
11-Digit CMS (5-4-2)
63629-2448-01

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