Esomeprazole Magnesium Granule, Delayed Release
NDC Package 68382-849-94

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

Package Information

Esomeprazole Magnesium granules is esomeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). This formulation utilizes a granule, delayed release delivery system. Marketed by Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 68382-849 and is authorized under FDA application ANDA206055.

Identification & Billing

NDC Package Code
68382-849-94
Package Description
30 GRANULE, DELAYED RELEASE in 1 CARTON
Product Code
68382-849
11-Digit Billing Format
68382084994
RxNorm Crosswalk
  • RxCUI: 692576 - esomeprazole 20 MG Granules for Delayed Release Oral Suspension
  • RxCUI: 692576 - esomeprazole 20 MG Granules for Oral Suspension
  • RxCUI: 692576 - esomeprazole (as esomeprazole magnesium) 20 MG Granules for Delayed Release Oral Suspension
  • RxCUI: 692578 - esomeprazole 40 MG Granules for Delayed Release Oral Suspension
  • RxCUI: 692578 - esomeprazole 40 MG Granules for Oral Suspension

Clinical Specifications

Proprietary Name
Esomeprazole Magnesium
Non-Proprietary Name
Esomeprazole Magnesium
Substance Name
Esomeprazole Magnesium Dihydrate
Dosage Form
Granule, Delayed Release - A small medicinal particle or grain to which an enteric or other coating has been applied, thus delaying release of the drug until its passage into the intestines.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ESOMEPRAZOLE MAGNESIUM DIHYDRATE 40 mg/1
Pharmacologic Class
Usage Information
Esomeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Esomeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). If you are self-treating with this medication, over-the-counter esomeprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Regulatory & Marketing

Labeler Name
Zydus Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA206055
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-30-2023
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 68382-849-94 identifies a specific commercial package of 30 granule, delayed release in 1 carton of Esomeprazole Magnesium, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. This granule, delayed release is formulated for oral use and contains esomeprazole magnesium dihydrate 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 Zydus Pharmaceuticals Usa Inc. on June 30, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Esomeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Esomeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). If you are self-treating with this medication, over-the-counter esomeprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

How is this Zydus Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68382084994. 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)
68382-849-94
11-Digit CMS (5-4-2)
68382-0849-94

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