Omega-3-acid Ethyl Esters
NDC Package 69837-170-05

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 inactivated by the FDA.

Omega-3-acid Ethyl Esters is a . Marketed by International Brand Management Inc, this product is identified by NDC 69837-170 and is authorized under FDA application ANDA090973.

Identification & Billing

NDC Package Code
69837-170-05
Package Description
120 CAPSULE in 1 BOTTLE / 1 g in 1 CAPSULE (69837-170-31)
Product Code
69837-170
11-Digit Billing Format
69837017005
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Omega-3-acid Ethyl Esters
Dosage Form
-

Regulatory & Marketing

Labeler Name
International Brand Management Inc
FDA Application #
ANDA090973
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-09-2016
Listing Expiration
12-31-2019
Exclude Flag
I
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 (69837-170). Click a package code to view its specific billing and regulatory data.

69837-170-03
30 CAPSULE in 1 BOTTLE / 1 g in 1 CAPSULE (69837-170-02)
69837-170-30
30 CAPSULE in 1 BOTTLE / 1 g in 1 CAPSULE (69837-170-31)

* 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 69837-170-05 identifies a specific commercial package of 120 capsule in 1 bottle / 1 g in 1 capsule (69837-170-31) of Omega-3-acid Ethyl Esters, labeled by International Brand Management Inc. 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 International Brand Management Inc on April 09, 2016. The current certification is valid through December 31, 2019.

How is this International Brand Management Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69837017005. 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)
69837-170-05
11-Digit CMS (5-4-2)
69837-0170-05

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