Sulfasalazine Tablet
NDC Package 59762-5000-2

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 delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 59762-5000 and is authorized under FDA application NDA007073.

Identification & Billing

NDC Package Code
59762-5000-2
Package Description
300 TABLET in 1 BOTTLE
Product Code
59762-5000
11-Digit Billing Format
59762500002
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
300 EA
RxNorm Crosswalk

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.
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
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA007073
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
07-01-2003
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 (59762-5000). Click a package code to view its specific billing and regulatory data.

59762-5000-1
100 TABLET in 1 BOTTLE
59762-5000-5
1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE
59762-5000-6
1 BOTTLE in 1 CARTON / 300 TABLET 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 59762-5000-2 identifies a specific commercial package of 300 tablet in 1 bottle of Sulfasalazine, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This tablet 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 Mylan Pharmaceuticals Inc. on July 01, 2003. 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 Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59762500002. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 300 total billable units per package. 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 (5-4-1)
59762-5000-2
11-Digit CMS (5-4-2)
59762-5000-02

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