Balsalazide Disodium
NDC Package 49884-367-05

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Balsalazide Disodium is balsalazide is used to treat a certain bowel disease (ulcerative colitis). Marketed by Par Pharmaceutical Inc., this product is identified by NDC 49884-367 and is authorized under FDA application ANDA206336.

Identification & Billing

NDC Package Code
49884-367-05
Package Description
500 TABLET in 1 BOTTLE
Product Code
49884-367
11-Digit Billing Format
49884036705

Clinical Specifications

Proprietary Name
Balsalazide Disodium
Dosage Form
-
Usage Information
Balsalazide is used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain. Balsalazide belongs to a class of drugs known as aminosalicylates. It works by decreasing swelling in the colon.

Regulatory & Marketing

Labeler Name
Par Pharmaceutical Inc.
FDA Application #
ANDA206336
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-08-2015
End Marketing Date
09-08-2015
Listing Expiration
09-08-2015
Exclude Flag
D
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 (49884-367). Click a package code to view its specific billing and regulatory data.

49884-367-13
180 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 49884-367-05 identifies a specific commercial package of 500 tablet in 1 bottle of Balsalazide Disodium, labeled by Par Pharmaceutical Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Par Pharmaceutical Inc. on September 08, 2015. The current certification is valid through September 08, 2015.

What are the primary indications for this medication?

Balsalazide is used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain. Balsalazide belongs to a class of drugs known as aminosalicylates. It works by decreasing swelling in the colon.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49884036705. 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)
49884-367-05
11-Digit CMS (5-4-2)
49884-0367-05

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