Naproxen Tablet, Delayed Release
NDC Package 11534-211-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Naproxen tablets is see also Warning section. This formulation utilizes a tablet, delayed release delivery system. Marketed by Sunrise Pharmaceutical, Inc., this product is identified by NDC 11534-211 and is authorized under FDA application ANDA091432.

Identification & Billing

NDC Package Code
11534-211-01
Package Description
100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Product Code
11534-211
11-Digit Billing Format
11534021101
RxNorm Crosswalk
  • RxCUI: 311915 - naproxen 500 MG Delayed Release Oral Tablet
  • RxCUI: 311915 - naproxen (as naproxen sodium) 500 MG Delayed Release Oral Tablet
  • RxCUI: 603103 - naproxen 375 MG Delayed Release Oral Tablet
  • RxCUI: 603103 - naproxen 375 MG (as naproxen sodium 413 MG) Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Naproxen
Non-Proprietary Name
Naproxen
Substance Name
Naproxen
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NAPROXEN 375 mg/1
Pharmacologic Class
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
Sunrise Pharmaceutical, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA091432
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-09-2025
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 11534-211-01 identifies a specific commercial package of 100 tablet, delayed release in 1 bottle, plastic of Naproxen, a human prescription drug labeled by Sunrise Pharmaceutical, Inc.. This tablet, delayed release is formulated for oral use and contains naproxen 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 Sunrise Pharmaceutical, Inc. on December 09, 2025. The current certification is valid through December 31, 2026.

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 Sunrise Pharmaceutical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11534021101. 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)
11534-211-01
11-Digit CMS (5-4-2)
11534-0211-01

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