Naproxen And Esomeprazole Magnesium Tablet, Delayed Release
NDC Package 76420-889-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Naproxen And Esomeprazole Magnesium tablets is naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers.The naproxen component of naproxen and esomeprazole magnesium delayed-release tablet is indicated for relief of signs and symptoms of:• osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. This formulation utilizes a tablet, delayed release delivery system. Marketed by Asclemed Usa, Inc., this product is identified by NDC 76420-889 and is authorized under FDA application ANDA204206.

Identification & Billing

NDC Package Code
76420-889-01
Package Description
100 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
76420-889
11-Digit Billing Format
76420088901
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 994005 - naproxen 375 MG / esomeprazole magnesium 20 MG Delayed Release Oral Tablet
  • RxCUI: 994005 - esomeprazole 20 MG / naproxen 375 MG Delayed Release Oral Tablet
  • RxCUI: 994005 - esomeprazole (as esomeprazole magnesium) 20 MG / naproxen (as naproxen sodium) 375 MG Delayed Release Oral Tablet
  • RxCUI: 994008 - naproxen 500 MG / esomeprazole magnesium 20 MG Delayed Release Oral Tablet
  • RxCUI: 994008 - esomeprazole 20 MG / naproxen 500 MG Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Naproxen And Esomeprazole Magnesium
Non-Proprietary Name
Naproxen And Esomeprazole Magnesium
Substance Name
Esomeprazole Magnesium; Naproxen
Dosage Form
Tablet, Delayed Release - A solid dosage form 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)
Pharmacologic Class
Usage Information
Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers.The naproxen component of naproxen and esomeprazole magnesium delayed-release tablet is indicated for relief of signs and symptoms of:• osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults.  • juvenile idiopathic arthritis (JIA) in adolescent patients.The esomeprazole magnesium component of naproxen and esomeprazole magnesium delayed-release tablet is indicated to decrease the risk of developing naproxen-associated gastric ulcers.  Limitations of Use:  • Do not substitute naproxen and esomeprazole magnesium delayed-release tablet with the single-ingredient products of naproxen and esomeprazole magnesium.• Naproxen and esomeprazole magnesium delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products.• Controlled studies do not extend beyond 6 months [seeUse in Specific Populations(8.4),Clinical Studies(14)].

Regulatory & Marketing

Labeler Name
Asclemed Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA204206
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-18-2020
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 (76420-889). Click a package code to view its specific billing and regulatory data.

76420-889-30
30 TABLET, DELAYED RELEASE in 1 BOTTLE
76420-889-60
60 TABLET, DELAYED RELEASE in 1 BOTTLE
76420-889-90
90 TABLET, 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 76420-889-01 identifies a specific commercial package of 100 tablet, delayed release in 1 bottle of Naproxen And Esomeprazole Magnesium, a human prescription drug labeled by Asclemed Usa, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet, delayed release is formulated for oral use and contains esomeprazole magnesium; naproxen 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 Asclemed Usa, Inc. on February 18, 2020. The current certification is valid through December 31, 2026.

How is this Asclemed Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76420088901. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
76420-889-01
11-Digit CMS (5-4-2)
76420-0889-01

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