Esomeprazole Dr Capsule, Delayed Release
NDC Package 72189-381-60

11-digit billing NDC: 72189038160 · Billing unit: EA · 60 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Esomeprazole Dr capsules is 1.1 Treatment of Gastroesophageal Reflux Disease (GERD)Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. This formulation utilizes a capsule, delayed release delivery system. Marketed by Direct_rx, this product is identified by NDC 72189-381 and is authorized under FDA application ANDA211977.

Identification & Billing

NDC Package Code
72189-381-60
Package Description
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product Code
72189-381
11-Digit Billing Format
72189038160
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
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 Dr
Non-Proprietary Name
Esomeprazole Dr
Substance Name
Esomeprazole Magnesium
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)
ESOMEPRAZOLE MAGNESIUM 20 mg/1
Pharmacologic Class
Usage Information
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole magnesium delayed-release capsules may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older. 1.2 Risk Reduction of NSAID-Associated Gastric UlcerEsomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (≥ 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer RecurrenceTriple Therapy (esomeprazole magnesium delayed-release capsules plus amoxicillin and clarithromycin): Esomeprazole magnesium delayed-release capsules, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Dosage and Administration (2) and Clinical Studies (14)]. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.4) and the prescribing information for clarithromycin]. 1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison SyndromeEsomeprazole magnesium delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.

Regulatory & Marketing

Labeler Name
Direct_rx
Product Type
Human Prescription Drug
FDA Application #
ANDA211977
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-13-2022
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 (72189-381). Click a package code to view its specific billing and regulatory data.

72189-381-30
30 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 72189-381-60 identifies a specific commercial package of 60 capsule, delayed release in 1 bottle of Esomeprazole Dr, a human prescription drug labeled by Direct_rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This capsule, delayed release 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 Direct_rx on September 13, 2022. The current certification is valid through December 31, 2026.

How is this Direct_rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189038160. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 total billable units per package. 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)
72189-381-60
11-Digit CMS (5-4-2)
72189-0381-60

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