Naproxen Sodium 220mg Tablet
NDC Package 53329-688-30

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Naproxen Sodium 220mg (naproxen sodium) tablets is naproxen is used to relieve pain from various conditions. This formulation utilizes a tablet delivery system. Marketed by Medline Industries, Lp, this product is identified by NDC 53329-688 and is authorized under FDA application ANDA090545.

Identification & Billing

NDC Package Code
53329-688-30
Package Description
100 TABLET in 1 BOTTLE
Product Code
53329-688
11-Digit Billing Format
53329068830
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Naproxen Sodium 220mg
Non-Proprietary Name
Naproxen Sodium
Substance Name
Naproxen Sodium
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NAPROXEN SODIUM 220 mg/1
Pharmacologic Class
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
Medline Industries, Lp
Product Type
Human Otc Drug
FDA Application #
ANDA090545
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-01-2018
End Marketing Date
06-30-2026
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 53329-688-30 identifies a specific commercial package of 100 tablet in 1 bottle of Naproxen Sodium 220mg, a human over the counter drug labeled by Medline Industries, Lp. This tablet 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 Medline Industries, Lp on August 01, 2018.

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 Medline Industries, Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53329068830. 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)
53329-688-30
11-Digit CMS (5-4-2)
53329-0688-30

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