Naproxen Sodium Tablet
NDC Package 0280-0048-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Naproxen Sodium tablets is naproxen is used to relieve pain from various conditions. This formulation utilizes a tablet delivery system. Marketed by Bayer Healthcare Llc., this product is identified by NDC 0280-0048.

Identification & Billing

NDC Package Code
0280-0048-01
Package Description
25 BAG in 1 CONTAINER / 1192676 TABLET in 1 BAG
Product Code
0280-0048
11-Digit Billing Format
00280004801

Clinical Specifications

Proprietary Name
Naproxen Sodium
Non-Proprietary Name
Naproxen Sodium
Substance Name
Naproxen Sodium
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Active Ingredient(s)
NAPROXEN SODIUM 220 mg/1
Usage Information
Naproxen is used to relieve pain from various conditions. 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. See also Warning section. Some brands of sustained-release naproxen take longer to be absorbed and are not recommended for pain that needs quick relief (such as during a gout attack). Ask your doctor or pharmacist if you have questions about your particular brand.

Regulatory & Marketing

Labeler Name
Bayer Healthcare Llc.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
07-26-2002
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 0280-0048-01 identifies a specific commercial package of 25 bag in 1 container / 1192676 tablet in 1 bag of Naproxen Sodium (UNFINISHED drug), drug for further processing labeled by Bayer Healthcare Llc.. This tablet is formulated for 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 Bayer Healthcare Llc. on July 26, 2002. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Naproxen is used to relieve pain from various conditions. 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. See also Warning section. Some brands of sustained-release naproxen take longer to be absorbed and are not recommended for pain that needs quick relief (such as during a gout attack). Ask your doctor or pharmacist if you have questions about your particular brand.

How is this Bayer Healthcare Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00280004801. 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 (4-4-2)
0280-0048-01
11-Digit CMS (5-4-2)
00280-0048-01

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