Olsalazine Sodium Powder
NDC Package 84206-0071-1

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.

Olsalazine Sodium powders is olsalazine is used to treat a certain type of bowel disease called ulcerative colitis. This formulation utilizes a powder delivery system. Marketed by Matrix Pharmacorp Private Limited, this product is identified by NDC 84206-0071.

Identification & Billing

NDC Package Code
84206-0071-1
Package Description
100 kg in 1 DRUM
Product Code
84206-0071
11-Digit Billing Format
84206007101

Clinical Specifications

Proprietary Name
Olsalazine Sodium
Non-Proprietary Name
Olsalazine Sodium
Substance Name
Olsalazine Sodium
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
OLSALAZINE SODIUM 1 kg/kg
Usage Information
Olsalazine is used to treat a certain type of bowel disease called ulcerative colitis. It does not cure ulcerative colitis, but it may decrease symptoms such as stomach pain, diarrhea, and rectal bleeding caused by irritation/swelling of the colon/rectum. After an attack is treated, olsalazine is used to increase the amount of time between attacks. Olsalazine is a salicylate anti-inflammatory drug. It is believed to work by blocking the production of certain natural substances (e.g., prostaglandins) that may cause pain and swelling.

Regulatory & Marketing

Labeler Name
Matrix Pharmacorp Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
10-10-2024
Listing Expiration
12-31-2026
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 84206-0071-1 identifies a specific commercial package of 100 kg in 1 drum of Olsalazine Sodium (UNFINISHED drug), a bulk ingredient labeled by Matrix Pharmacorp Private Limited. This powder is formulated for use and contains olsalazine sodium 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 Matrix Pharmacorp Private Limited on October 10, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Olsalazine is used to treat a certain type of bowel disease called ulcerative colitis. It does not cure ulcerative colitis, but it may decrease symptoms such as stomach pain, diarrhea, and rectal bleeding caused by irritation/swelling of the colon/rectum. After an attack is treated, olsalazine is used to increase the amount of time between attacks. Olsalazine is a salicylate anti-inflammatory drug. It is believed to work by blocking the production of certain natural substances (e.g., prostaglandins) that may cause pain and swelling.

How is this Matrix Pharmacorp Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84206007101. 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)
84206-0071-1
11-Digit CMS (5-4-2)
84206-0071-01

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