Sulfasalazine Tablet, Delayed Release
NDC Package 11534-201-01

11-digit billing NDC: 11534020101
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Sulfasalazine tablets is sULFASALAZINE DELAYED RELEASE Tablets, USP are indicated:a)in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis;b)for the prolongation of the remission period between acute attacks of ulcerative colitis;c)in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g., an insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs); andd)in the treatment of pediatric patients with polyarticular-course1juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs.SULFASALAZINE DELAYED RELEASE Tablets, USP are particularly indicated in patients with ulcerative colitis who cannot take uncoated sulfasalazine tablets because of gastrointestinal intolerance, and in whom there is evidence that this intolerance is not primarily the result of high blood levels of sulfapyridine and its metabolites, e.g., patients experiencing nausea and vomiting with the first few doses of the drug, or patients in whom a reduction in dosage does not alleviate the adverse gastrointestinal effects.In patients with rheumatoid arthritis or juvenile rheumatoid arthritis, rest and physiotherapy as indicated should be continued. 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
11534-201-01
Package Description
100 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
11534-201
11-Digit Billing Format
11534020101
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 DELAYED RELEASE Tablets, USP are indicated:a)in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis;b)for the prolongation of the remission period between acute attacks of ulcerative colitis;c)in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g., an insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs); andd)in the treatment of pediatric patients with polyarticular-course1juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs.SULFASALAZINE DELAYED RELEASE Tablets, USP are particularly indicated in patients with ulcerative colitis who cannot take uncoated sulfasalazine tablets because of gastrointestinal intolerance, and in whom there is evidence that this intolerance is not primarily the result of high blood levels of sulfapyridine and its metabolites, e.g., patients experiencing nausea and vomiting with the first few doses of the drug, or patients in whom a reduction in dosage does not alleviate the adverse gastrointestinal effects.In patients with rheumatoid arthritis or juvenile rheumatoid arthritis, rest and physiotherapy as indicated should be continued. Unlike anti-inflammatory drugs, SULFASALAZINE DELAYED RELEASE Tablets, USP do not produce an immediate response. Concurrent treatment with analgesics and/or nonsteroidal anti-inflammatory drugs is recommended at least until the effect of SULFASALAZINE DELAYED RELEASE Tablets, USP is apparent.

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.

11534-201-07
300 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 11534-201-01 identifies a specific commercial package of 100 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.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11534020101. 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)
11534-201-01
11-Digit CMS (5-4-2)
11534-0201-01

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