Naproxen Sodium
NDC Package 69848-009-01

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 discontinued by the firm.

Naproxen Sodium is see also Warning section. Marketed by Granules Usa, Inc., this product is identified by NDC 69848-009 and is authorized under FDA application ANDA091353.

Identification & Billing

NDC Package Code
69848-009-01
Package Description
10 TABLET in 1 BOTTLE
Product Code
69848-009
11-Digit Billing Format
69848000901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Naproxen Sodium
Dosage Form
-
Usage Information
See also Warning section. Naproxen is used to relieve pain from various conditions such as headache, muscle aches, tendonitis, dental pain, and menstrual cramps. It also reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Regulatory & Marketing

Labeler Name
Granules Usa, Inc.
FDA Application #
ANDA091353
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2019
End Marketing Date
12-31-2023
Listing Expiration
12-31-2023
Exclude Flag
D
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 69848-009-01 identifies a specific commercial package of 10 tablet in 1 bottle of Naproxen Sodium, labeled by Granules Usa, 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 Granules Usa, Inc. on July 01, 2019. The current certification is valid through December 31, 2023.

What are the primary indications for this medication?

See also Warning section. Naproxen is used to relieve pain from various conditions such as headache, muscle aches, tendonitis, dental pain, and menstrual cramps. It also reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

How is this Granules Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69848000901. 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)
69848-009-01
11-Digit CMS (5-4-2)
69848-0009-01

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