Esomeprazole Magnesium Capsule
NDC Package 69168-472-62

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Esomeprazole Magnesium (esomeprazole magnesium capsule, delayed release) capsules is esomeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). This formulation utilizes a capsule delivery system. Marketed by Allegiant Health, this product is identified by NDC 69168-472 and is authorized under FDA application ANDA212507.

Identification & Billing

NDC Package Code
69168-472-62
Package Description
3 BOTTLE in 1 CARTON / 14 CAPSULE in 1 BOTTLE
Product Code
11-Digit Billing Format
69168047262
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 Magnesium
Non-Proprietary Name
Esomeprazole Magnesium Capsule, Delayed Release
Substance Name
Esomeprazole Magnesium
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
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
Allegiant Health
Product Type
Human Otc Drug
FDA Application #
ANDA212507
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-15-2025
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 (69168-472). Click a package code to view its specific billing and regulatory data.

1 BOTTLE in 1 CARTON / 14 CAPSULE in 1 BOTTLE
14 CAPSULE in 1 BOTTLE
3 BOTTLE in 1 CARTON / 14 CAPSULE in 1 BOTTLE
1 BOTTLE in 1 CARTON / 14 CAPSULE 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 69168-472-62 identifies a specific commercial package of 3 bottle in 1 carton / 14 capsule in 1 bottle of Esomeprazole Magnesium, a human over the counter drug labeled by Allegiant Health. This capsule is formulated for oral use and contains esomeprazole magnesium 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 Allegiant Health on May 15, 2025. 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 Allegiant Health product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69168047262. 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)
69168-472-62
11-Digit CMS (5-4-2)
69168-0472-62

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