Esomeprazole Magnesium Capsule, Delayed Release
NDC Package 45865-163-60

11-digit billing NDC: 45865016360
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Esomeprazole Magnesium capsules is adultsEsomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed EE in adults. This formulation utilizes a capsule, delayed release delivery system. Marketed by Medsource Pharmaceuticals, this product is identified by NDC 45865-163 and is authorized under FDA application ANDA078279.

Identification & Billing

NDC Package Code
45865-163-60
Package Description
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product Code
45865-163
11-Digit Billing Format
45865016360
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
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
AdultsEsomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed EE in adults. 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.Pediatric Patients 12 Years to 17 Years of AgeEsomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age. 

Regulatory & Marketing

Labeler Name
Medsource Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA078279
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-10-2015
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (45865-163). Click a package code to view its specific billing and regulatory data.

45865-163-30
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 45865-163-60 identifies a specific commercial package of 60 capsule, delayed release in 1 bottle of Esomeprazole Magnesium, a human prescription drug labeled by Medsource Pharmaceuticals. 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 Medsource Pharmaceuticals on December 10, 2015. The current certification is valid through December 31, 2027.

How is this Medsource Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45865016360. 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)
45865-163-60
11-Digit CMS (5-4-2)
45865-0163-60

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