Balsalazide Disodium Capsule
NDC Package 60505-2575-7

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

Balsalazide Disodium capsules is balsalazide is used to treat a certain bowel disease (ulcerative colitis). This formulation utilizes a capsule delivery system. Marketed by Apotex Corp., this product is identified by NDC 60505-2575 and is authorized under FDA application ANDA077883.

Identification & Billing

NDC Package Code
60505-2575-7
Package Description
280 CAPSULE in 1 BOTTLE
Product Code
60505-2575
11-Digit Billing Format
60505257507
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
280 EA
RxNorm Crosswalk
RxCUI: 885857 - balsalazide disodium 750 MG Oral Capsule

Clinical Specifications

Proprietary Name
Balsalazide Disodium
Non-Proprietary Name
Balsalazide Disodium
Substance Name
Balsalazide Disodium
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BALSALAZIDE DISODIUM 750 mg/1
Pharmacologic Class
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
Apotex Corp.
Product Type
Human Prescription Drug
FDA Application #
ANDA077883
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-28-2007
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 (60505-2575). Click a package code to view its specific billing and regulatory data.

60505-2575-0
10 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK
60505-2575-3
30 CAPSULE in 1 BOTTLE
60505-2575-4
350 CAPSULE 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 60505-2575-7 identifies a specific commercial package of 280 capsule in 1 bottle of Balsalazide Disodium, a human prescription drug labeled by Apotex Corp.. This capsule is formulated for oral use and contains balsalazide disodium 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 Apotex Corp. on December 28, 2007. The current certification is valid through December 31, 2026.

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 Apotex Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60505257507. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 280 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)
60505-2575-7
11-Digit CMS (5-4-2)
60505-2575-07

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