Esomeprazole Magnesium Capsule, Delayed Release
NDC Package 72789-352-30

11-digit billing NDC: 72789035230
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Esomeprazole Magnesium capsules is esomeprazole magnesium delayed-release capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. This formulation utilizes a capsule, delayed release delivery system. Marketed by Pd-rx Pharmaceuticals, Inc., this product is identified by NDC 72789-352 and is authorized under FDA application ANDA205606.

Identification & Billing

NDC Package Code
72789-352-30
Package Description
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Product Code
72789-352
11-Digit Billing Format
72789035230
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
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)
ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20 mg/1
Pharmacologic Class
Usage Information
Esomeprazole magnesium delayed-release capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6.2)]. For information about contraindications of amoxicillin and clarithromycin, indicated in combination with esomeprazole magnesium delayed-release capsules for H. pylorieradication to reduce the risk of duodenal ulcer recurrence, refer to the Contraindications section of the respective prescribing information. Proton pump inhibitors (PPIs), including esomeprazole magnesium delayed-release capsules, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)] .

Regulatory & Marketing

Labeler Name
Pd-rx Pharmaceuticals, Inc.
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
12-31-2027
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 72789-352-30 identifies a specific commercial package of 30 capsule, delayed release in 1 bottle, plastic of Esomeprazole Magnesium, a human prescription drug labeled by Pd-rx Pharmaceuticals, Inc.. 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 Pd-rx Pharmaceuticals, Inc. on April 21, 2016. The current certification is valid through December 31, 2027.

How is this Pd-rx Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72789035230. 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)
72789-352-30
11-Digit CMS (5-4-2)
72789-0352-30

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