Esomeprazole Magnesium
NDC Package 71256-004-02

11-digit billing NDC: 71256000402
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.

Esomeprazole Magnesium is  is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Marketed by Cisen Pharmaceutical Co., Ltd., this product is identified by NDC 71256-004 and is authorized under FDA application ANDA213158.

Identification & Billing

NDC Package Code
71256-004-02
Package Description
90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC
Product Code
71256-004
11-Digit Billing Format
71256000402
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
  • RxCUI: 606730 - esomeprazole magnesium 40 MG Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Esomeprazole Magnesium
Dosage Form
-
Usage Information
Esomeprazole magnesium is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6.2)]. For information about contraindications of amoxicillin and clarithromycin, indicated in combination with Esomeprazole magnesium for H. pylori eradication to reduce the risk of duodenal ulcer recurrence, refer to the Contraindications section of the respective prescribing information. Proton pump inhibitors (PPIs), including Esomeprazole magnesium, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)] .

Regulatory & Marketing

Labeler Name
Cisen Pharmaceutical Co., Ltd.
FDA Application #
ANDA213158
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2023
Listing Expiration
12-31-2023
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 (71256-004). Click a package code to view its specific billing and regulatory data.

71256-004-01
30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC

* 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 71256-004-02 identifies a specific commercial package of 90 capsule, delayed release pellets in 1 bottle, plastic of Esomeprazole Magnesium, labeled by Cisen Pharmaceutical Co., Ltd.. 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 Cisen Pharmaceutical Co., Ltd. on January 01, 2023. The current certification is valid through December 31, 2023.

How is this Cisen Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71256000402. 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)
71256-004-02
11-Digit CMS (5-4-2)
71256-0004-02

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