Naproxen Sodium Tablet, Coated
NDC Package 41226-609-05

11-digit billing NDC: 41226060905
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Naproxen Sodium tablets is usestemporarily relieves minor aches and pains due to:minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever. This formulation utilizes a tablet, coated delivery system. Marketed by Kroger Company, this product is identified by NDC 41226-609 and is authorized under FDA application ANDA090545.

Identification & Billing

NDC Package Code
41226-609-05
Package Description
1 BOTTLE in 1 CARTON / 50 TABLET, COATED in 1 BOTTLE
Product Code
41226-609
11-Digit Billing Format
41226060905
RxNorm Crosswalk

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
Usestemporarily relieves minor aches and pains due to:minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever

Regulatory & Marketing

Labeler Name
Kroger Company
Product Type
Human Otc Drug
FDA Application #
ANDA090545
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-12-2021
Listing Expiration
12-31-2026
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 41226-609-05 identifies a specific commercial package of 1 bottle in 1 carton / 50 tablet, coated in 1 bottle of Naproxen Sodium, a human over the counter drug labeled by Kroger Company. 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 Kroger Company on June 12, 2021. The current certification is valid through December 31, 2026.

How is this Kroger Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41226060905. 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)
41226-609-05
11-Digit CMS (5-4-2)
41226-0609-05

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