Esomeprazole
NDC Package 69618-056-42

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Esomeprazole is adults 18 years of age and olderthis prodcut is to be used once a day (every 24 hours), every day for 14 daysmake take 1 to 4 days for full effect14-Day Course of Treatmentswallow 1 capsule with a glass of water before eating in the morningtake every day for 14 daysdo not take more than 1 capsule a dayswallow whole. Marketed by Reliable 1 Laboratories, this product is identified by NDC 69618-056 and is authorized under FDA application ANDA207673.

Identification & Billing

NDC Package Code
69618-056-42
Package Description
3 BOTTLE, PLASTIC in 1 CARTON / 14 CAPSULE in 1 BOTTLE, PLASTIC (69618-056-14)
Product Code
69618-056
11-Digit Billing Format
69618005642
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
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
Esomeprazole
Dosage Form
-
Usage Information
Adults 18 years of age and olderthis prodcut is to be used once a day (every 24 hours), every day for 14 daysmake take 1 to 4 days for full effect14-Day Course of Treatmentswallow 1 capsule with a glass of water before eating in the morningtake every day for 14 daysdo not take more than 1 capsule a dayswallow whole. Do not crush or chew capsules.do not use of more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)you may repeart a 14-day course every 4 monthsdo not take for more than 14 days or more often than every 4 mounths unless directed by a doctorchildren under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be cuased by a serious condition.

Regulatory & Marketing

Labeler Name
Reliable 1 Laboratories
FDA Application #
ANDA207673
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2018
Listing Expiration
12-31-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69618-056-42 identifies a specific commercial package of 3 bottle, plastic in 1 carton / 14 capsule in 1 bottle, plastic (69618-056-14) of Esomeprazole, labeled by Reliable 1 Laboratories. This product is billed for "EA" each discreet unit and contains an estimated amount of 3 billable units per package. 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 Reliable 1 Laboratories on November 01, 2018. The current certification is valid through December 31, 2022.

How is this Reliable 1 Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69618005642. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 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)
69618-056-42
11-Digit CMS (5-4-2)
69618-0056-42

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