Esomeprazole Magnesium Capsule, Delayed Release
NDC Package 65862-784-01

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

Esomeprazole Magnesium capsules is esomeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). This formulation utilizes a capsule, delayed release delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-784 and is authorized under FDA application ANDA205606.

Identification & Billing

NDC Package Code
65862-784-01
Package Description
100 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product Code
65862-784
11-Digit Billing Format
65862078401
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
Non-Proprietary Name
Esomeprazole Magnesium
Substance Name
Esomeprazole Magnesium Dihydrate
Dosage Form
Capsule, Delayed Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
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
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA205606
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-21-2016
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65862-784). Click a package code to view its specific billing and regulatory data.

65862-784-25
25000 CAPSULE, DELAYED RELEASE in 1 BAG
65862-784-30
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE
65862-784-39
3000 CAPSULE, DELAYED RELEASE in 1 BAG
65862-784-78
10 BLISTER PACK in 1 CARTON / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (65862-784-10)
65862-784-90
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE
65862-784-99
1000 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 65862-784-01 identifies a specific commercial package of 100 capsule, delayed release in 1 bottle of Esomeprazole Magnesium, a human prescription drug labeled by Aurobindo Pharma Limited. This capsule, 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 Aurobindo Pharma Limited on April 21, 2016. 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 Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862078401. 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)
65862-784-01
11-Digit CMS (5-4-2)
65862-0784-01

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