Equaline Esomeprazole Magnesium
NDC Package 41163-539-01

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.

Equaline Esomeprazole Magnesium is •adults 18 years of age and older•this product is to be used once a day (every 24 hours), every day for 14 days•may take 1 to 4 days for full effect14-Day Course of Treatment•swallow 1 capsule with a glass of water before eating in the morning•take every day for 14 days•do not take more than 1 capsule a day•swallow whole. Marketed by United Natural Foods, Inc. Dba Unfi, this product is identified by NDC 41163-539 and is authorized under FDA application ANDA207193.

Identification & Billing

NDC Package Code
41163-539-01
Package Description
1 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product Code
41163-539
11-Digit Billing Format
41163053901
RxNorm Crosswalk
  • RxCUI: 606726 - esomeprazole magnesium 20 MG Delayed Release Oral Capsule
  • RxCUI: 606726 - esomeprazole 20 MG Delayed Release Oral Capsule
  • RxCUI: 606726 - esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule
  • RxCUI: 606726 - esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Equaline Esomeprazole Magnesium
Dosage Form
-
Usage Information
•adults 18 years of age and older•this product is to be used once a day (every 24 hours), every day for 14 days•may take 1 to 4 days for full effect14-Day Course of Treatment•swallow 1 capsule with a glass of water before eating in the morning•take every day for 14 days•do not take more than 1 capsule a day•swallow whole. Do not crush or chew capsules.•do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)•you may repeat a 14-day course every 4 months•do not take for more than 14 days or more often than every 4 months unless directed by a doctor•children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

Regulatory & Marketing

Labeler Name
United Natural Foods, Inc. Dba Unfi
FDA Application #
ANDA207193
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-25-2017
Listing Expiration
12-31-2025
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 (41163-539). Click a package code to view its specific billing and regulatory data.

41163-539-02
2 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
41163-539-03
3 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE 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 41163-539-01 identifies a specific commercial package of 1 bottle in 1 carton / 14 capsule, delayed release in 1 bottle of Equaline Esomeprazole Magnesium, labeled by United Natural Foods, Inc. Dba Unfi. 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 United Natural Foods, Inc. Dba Unfi on September 25, 2017. The current certification is valid through December 31, 2025.

How is this United Natural Foods, Inc. Dba Unfi product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41163053901. 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)
41163-539-01
11-Digit CMS (5-4-2)
41163-0539-01

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