Clear Choice Naproxen Sodium
NDC Package 53185-004-00

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

Package Information

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

Clear Choice Naproxen Sodium is do not take more than directed the smallest effective dose should be useddo not take longer than 10 days, unless directed by a doctor (see Warnings) drink a full glass of water with each doseAdults and children 12 years and older take 1 tablet every 8 to 12 hours while symptoms lastfor the first dose you may take 2 tablets within the first hourdo not exceed 2 tablets in any 8- to 12-hour perioddo not exceed 3 tablets in a 24-hour periodChildren under 12 years ask a doctor. Marketed by Athlete's Needs Inc, this product is identified by NDC 53185-004 and is authorized under FDA application ANDA079096.

Identification & Billing

NDC Package Code
53185-004-00
Package Description
1 BOTTLE in 1 CARTON / 50 TABLET in 1 BOTTLE
Product Code
53185-004
11-Digit Billing Format
53185000400
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clear Choice Naproxen Sodium
Dosage Form
-
Usage Information
Do not take more than directed the smallest effective dose should be useddo not take longer than 10 days, unless directed by a doctor (see Warnings) drink a full glass of water with each doseAdults and children 12 years and older take 1 tablet every 8 to 12 hours while symptoms lastfor the first dose you may take 2 tablets within the first hourdo not exceed 2 tablets in any 8- to 12-hour perioddo not exceed 3 tablets in a 24-hour periodChildren under 12 years ask a doctor

Regulatory & Marketing

Labeler Name
Athlete's Needs Inc
FDA Application #
ANDA079096
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-06-2013
Listing Expiration
12-31-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53185-004-00 identifies a specific commercial package of 1 bottle in 1 carton / 50 tablet in 1 bottle of Clear Choice Naproxen Sodium, labeled by Athlete's Needs Inc. 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 Athlete's Needs Inc on May 06, 2013. The current certification is valid through December 31, 2018.

How is this Athlete's Needs Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53185000400. 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)
53185-004-00
11-Digit CMS (5-4-2)
53185-0004-00

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