Sulfasalazine Tablet, Delayed Release
NDC Package 11534-201-07

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

Package Information

Sulfasalazine tablets is sulfasalazine is used to treat a certain type of bowel disease called ulcerative colitis. This formulation utilizes a tablet, delayed release delivery system. Marketed by Sunrise Pharmaceutical, Inc., this product is identified by NDC 11534-201 and is authorized under FDA application ANDA075339.

Identification & Billing

NDC Package Code
11534-201-07
Package Description
300 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
11534-201
11-Digit Billing Format
11534020107
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sulfasalazine
Non-Proprietary Name
Sulfasalazine
Substance Name
Sulfasalazine
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)
SULFASALAZINE 500 mg/1
Pharmacologic Class
Usage Information
Sulfasalazine is used to treat a certain type of bowel disease called ulcerative colitis. This medication does not cure this condition, but it helps decrease symptoms such as fever, stomach pain, diarrhea, and rectal bleeding. After an attack is treated, sulfasalazine is also used to increase the amount of time between attacks. This medication works by reducing irritation and swelling in the large intestines. In addition, delayed-release tablets of sulfasalazine are used to treat rheumatoid arthritis. Sulfasalazine helps to reduce joint pain, swelling, and stiffness. Early treatment of rheumatoid arthritis with sulfasalazine helps to reduce/prevent further joint damage so you can do more of your normal daily activities. This medication is used with other drugs, rest, and physical therapy in patients who have not responded to other medications (salicylates, nonsteroidal anti-inflammatory drugs-NSAIDs).

Regulatory & Marketing

Labeler Name
Sunrise Pharmaceutical, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA075339
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-11-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (11534-201). Click a package code to view its specific billing and regulatory data.

11534-201-01
100 TABLET, DELAYED RELEASE in 1 BOTTLE

* 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 11534-201-07 identifies a specific commercial package of 300 tablet, delayed release in 1 bottle of Sulfasalazine, a human prescription drug labeled by Sunrise Pharmaceutical, Inc.. This tablet, delayed release is formulated for oral use and contains sulfasalazine 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 11, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Sulfasalazine is used to treat a certain type of bowel disease called ulcerative colitis. This medication does not cure this condition, but it helps decrease symptoms such as fever, stomach pain, diarrhea, and rectal bleeding. After an attack is treated, sulfasalazine is also used to increase the amount of time between attacks. This medication works by reducing irritation and swelling in the large intestines. In addition, delayed-release tablets of sulfasalazine are used to treat rheumatoid arthritis. Sulfasalazine helps to reduce joint pain, swelling, and stiffness. Early treatment of rheumatoid arthritis with sulfasalazine helps to reduce/prevent further joint damage so you can do more of your normal daily activities. This medication is used with other drugs, rest, and physical therapy in patients who have not responded to other medications (salicylates, nonsteroidal anti-inflammatory drugs-NSAIDs).

How is this Sunrise Pharmaceutical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11534020107. 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)
11534-201-07
11-Digit CMS (5-4-2)
11534-0201-07

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