Naproxen
NDC Package 16590-163-82

11-digit billing NDC: 16590016382
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.

Naproxen is carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. Marketed by Stat Rx Usa Llc, this product is identified by NDC 16590-163 and is authorized under FDA application ANDA074201.

Identification & Billing

NDC Package Code
16590-163-82
Package Description
180 TABLET in 1 BOTTLE
Product Code
16590-163
11-Digit Billing Format
16590016382
RxNorm Crosswalk
RxCUI: 198014 - naproxen 500 MG Oral Tablet

Clinical Specifications

Proprietary Name
Naproxen
Dosage Form
-
Usage Information
Carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Naproxen tablets are indicated:For the relief of the signs and symptoms of rheumatoid arthritisFor the relief of the signs and symptoms of osteoarthritisFor the relief of the signs and symptoms of ankylosing spondylitisFor the relief of the signs and symptoms of juvenile arthritisNaproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight.Naproxen tablets are also indicated:For the relief of the signs and symptoms of tendonitisFor the relief of the signs and symptoms of bursitisFor the relief of the signs and symptoms of acute goutFor the management of painFor the management of primary dysmenorrhea

Regulatory & Marketing

Labeler Name
Stat Rx Usa Llc
FDA Application #
ANDA074201
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-18-2011
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 (16590-163). Click a package code to view its specific billing and regulatory data.

16590-163-14
14 TABLET in 1 BOTTLE
16590-163-20
20 TABLET in 1 BOTTLE
16590-163-28
28 TABLET in 1 BOTTLE
16590-163-30
30 TABLET in 1 BOTTLE
16590-163-56
56 TABLET in 1 BOTTLE
16590-163-60
60 TABLET in 1 BOTTLE
16590-163-72
120 TABLET in 1 BOTTLE
16590-163-90
90 TABLET 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 16590-163-82 identifies a specific commercial package of 180 tablet in 1 bottle of Naproxen, 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 18, 2011. The current certification is valid through December 31, 2017.

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: 16590016382. 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)
16590-163-82
11-Digit CMS (5-4-2)
16590-0163-82

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