Naproxen Sodium Tablet, Coated
NDC Package 57344-244-03

11-digit billing NDC: 57344024403
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Naproxen Sodium tablets is do not take more than directedthe smallest effective dose should be useddrink a full glass of water with each doseAdults and children 12 years and oldertake 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 yearsask a doctor. This formulation utilizes a tablet, coated delivery system. Marketed by Aaa Pharmaceutical, Inc., this product is identified by NDC 57344-244 and is authorized under FDA application ANDA079096.

Identification & Billing

NDC Package Code
57344-244-03
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
Product Code
57344-244
11-Digit Billing Format
57344024403

Clinical Specifications

Proprietary Name
Naproxen Sodium
Non-Proprietary Name
Naproxen Sodium
Substance Name
Naproxen Sodium
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NAPROXEN SODIUM 220 mg/1
Pharmacologic Class
Usage Information
Do not take more than directedthe smallest effective dose should be useddrink a full glass of water with each doseAdults and children 12 years and oldertake 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 yearsask a doctor

Regulatory & Marketing

Labeler Name
Aaa Pharmaceutical, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA079096
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-30-2026
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 57344-244-03 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 100 tablet, coated in 1 bottle, plastic of Naproxen Sodium, a human over the counter drug labeled by Aaa Pharmaceutical, Inc.. This tablet, coated is formulated for oral use and contains naproxen sodium 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 Aaa Pharmaceutical, Inc. on April 30, 2026. The current certification is valid through December 31, 2027.

How is this Aaa Pharmaceutical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57344024403. 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)
57344-244-03
11-Digit CMS (5-4-2)
57344-0244-03

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