Naproxen
NDC Package 33261-082-60

11-digit billing NDC: 33261008260 · Billing unit: EA · 60 EA per package
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.

Naproxen is carefully consider the potential benefits and risks of Naproxen Delayed-Release Tablets USP and other treatment options before deciding to use Naproxen Delayed-Release Tablets USP. Marketed by Aidarex Pharmaceuticals Llc, this product is identified by NDC 33261-082 and is authorized under FDA application ANDA075227.

Identification & Billing

NDC Package Code
33261-082-60
Package Description
60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Product Code
33261-082
11-Digit Billing Format
33261008260
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
  • RxCUI: 311915 - naproxen 500 MG Delayed Release Oral Tablet
  • RxCUI: 311915 - naproxen (as naproxen sodium) 500 MG Delayed Release Oral Tablet
  • RxCUI: 603103 - naproxen 375 MG Delayed Release Oral Tablet
  • RxCUI: 603103 - naproxen 375 MG (as naproxen sodium 413 MG) Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Naproxen
Dosage Form
-
Usage Information
Carefully consider the potential benefits and risks of Naproxen Delayed-Release Tablets USP and other treatment options before deciding to use Naproxen Delayed-Release Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Naproxen Delayed-Release Tablets USP 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, USP as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight.Naproxen Delayed-Release Tablets USP are not recommended for initial treatment of acute pain because the absorption of naproxen, USP is delayed compared to absorption from other naproxen-containing products (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

Regulatory & Marketing

Labeler Name
Aidarex Pharmaceuticals Llc
FDA Application #
ANDA075227
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-31-1998
Listing Expiration
12-31-2019
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 33261-082-60 identifies a specific commercial package of 60 tablet, delayed release in 1 bottle, plastic of Naproxen, labeled by Aidarex Pharmaceuticals Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. 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 Aidarex Pharmaceuticals Llc on July 31, 1998. The current certification is valid through December 31, 2019.

How is this Aidarex Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33261008260. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
33261-082-60
11-Digit CMS (5-4-2)
33261-0082-60

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