Esomeprazole Magnesium Trihydrate Powder
NDC Package 72166-017-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Esomeprazole Magnesium Trihydrate powders is esomeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). This formulation utilizes a powder delivery system. Marketed by Kalintis Healthcare Private Limited, this product is identified by NDC 72166-017.

Identification & Billing

NDC Package Code
72166-017-01
Package Description
50 kg in 1 DRUM
Product Code
72166-017
11-Digit Billing Format
72166001701

Clinical Specifications

Proprietary Name
Esomeprazole Magnesium Trihydrate
Non-Proprietary Name
Esomeprazole Magnesium Trihydrate
Substance Name
Esomeprazole Magnesium
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
ESOMEPRAZOLE MAGNESIUM 1 kg/kg
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
Kalintis Healthcare Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-12-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 72166-017-01 identifies a specific commercial package of 50 kg in 1 drum of Esomeprazole Magnesium Trihydrate (UNFINISHED drug), a bulk ingredient labeled by Kalintis Healthcare Private Limited. This powder is formulated for 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 Kalintis Healthcare Private Limited on April 12, 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 Kalintis Healthcare Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72166001701. 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)
72166-017-01
11-Digit CMS (5-4-2)
72166-0017-01

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