Vimovo
NDC Package 16590-957-30

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Vimovo is a medication used to treat the signs and symptoms of rheumatoid arthritis, osteoarthritis, juvenile idiopathic arthritis, and ankylosing spondylitis when there is a high risk for stomach bleeding/ulcer. Marketed by Stat Rx Usa Llc, this product is identified by NDC 16590-957 and is authorized under FDA application NDA022511.

Identification & Billing

NDC Package Code
16590-957-30
Package Description
30 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
16590-957
11-Digit Billing Format
16590095730
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: 994007 - Vimovo 375 MG / 20 MG Delayed Release Oral Tablet
  • RxCUI: 994007 - esomeprazole 20 MG / naproxen 375 MG Delayed Release Oral Tablet [Vimovo]

Clinical Specifications

Proprietary Name
Vimovo
Dosage Form
-
Usage Information
This medication is used to treat the signs and symptoms of rheumatoid arthritis, osteoarthritis, juvenile idiopathic arthritis, and ankylosing spondylitis when there is a high risk for stomach bleeding/ulcer. This product contains 2 medications: esomeprazole and naproxen. This product should not be used to relieve sudden pain. The naproxen starts to work slower than other naproxen products because of a special coating (delayed-release). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It reduces pain, swelling, and joint stiffness. Naproxen can cause stomach ulcers, especially in patients with a history of stomach ulcers. Esomeprazole is a proton pump inhibitor (PPI) that blocks acid production in the stomach. This combination provides the benefits of naproxen and may reduce the risk of ulcers or bleeding that can occur with naproxen use.

Regulatory & Marketing

Labeler Name
Stat Rx Usa Llc
FDA Application #
NDA022511
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2011
Listing Expiration
12-31-2017
Exclude Flag
I
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 (16590-957). Click a package code to view its specific billing and regulatory data.

16590-957-60
60 TABLET, DELAYED RELEASE in 1 BOTTLE
16590-957-90
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 16590-957-30 identifies a specific commercial package of 30 tablet, delayed release in 1 bottle of Vimovo, labeled by Stat Rx Usa Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Stat Rx Usa Llc on July 01, 2011. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication is used to treat the signs and symptoms of rheumatoid arthritis, osteoarthritis, juvenile idiopathic arthritis, and ankylosing spondylitis when there is a high risk for stomach bleeding/ulcer. This product contains 2 medications: esomeprazole and naproxen. This product should not be used to relieve sudden pain. The naproxen starts to work slower than other naproxen products because of a special coating (delayed-release). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It reduces pain, swelling, and joint stiffness. Naproxen can cause stomach ulcers, especially in patients with a history of stomach ulcers. Esomeprazole is a proton pump inhibitor (PPI) that blocks acid production in the stomach. This combination provides the benefits of naproxen and may reduce the risk of ulcers or bleeding that can occur with naproxen use.

How is this Stat Rx Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16590095730. 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)
16590-957-30
11-Digit CMS (5-4-2)
16590-0957-30

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