Sulfasalazine Tablet
NDC Package 57294-021-01

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.

Sulfasalazine tablets is sulfasalazine is used to treat a certain type of bowel disease called ulcerative colitis. This formulation utilizes a tablet delivery system. Marketed by Haupt Pharma Wuelfing Gmbh., this product is identified by NDC 57294-021.

Identification & Billing

NDC Package Code
57294-021-01
Package Description
1 BAG in 1 PAIL / 16200 TABLET in 1 BAG
Product Code
57294-021
11-Digit Billing Format
57294002101

Clinical Specifications

Proprietary Name
Sulfasalazine
Non-Proprietary Name
Sulfasalazine
Substance Name
Sulfasalazine
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Active Ingredient(s)
SULFASALAZINE 500 mg/1
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
Haupt Pharma Wuelfing Gmbh.
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
03-01-2022
Listing Expiration
12-31-2027
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 57294-021-01 identifies a specific commercial package of 1 bag in 1 pail / 16200 tablet in 1 bag of Sulfasalazine (UNFINISHED drug), drug for further processing labeled by Haupt Pharma Wuelfing Gmbh.. This tablet is formulated for 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 Haupt Pharma Wuelfing Gmbh. on March 01, 2022. The current certification is valid through December 31, 2027.

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 Haupt Pharma Wuelfing Gmbh. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57294002101. 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)
57294-021-01
11-Digit CMS (5-4-2)
57294-0021-01

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