Chlorhexidine Gluconate
NDC Package 60505-0355-0

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

Chlorhexidine Gluconate is a medication used along with regular tooth brushing/flossing to treat gingivitis, a gum disease that causes red, swollen, and easily bleeding gums. Marketed by Apotex Corp, this product is identified by NDC 60505-0355 and is authorized under FDA application ANDA075561.

Identification & Billing

NDC Package Code
60505-0355-0
Package Description
475 mL in 1 BOTTLE, PLASTIC
Product Code
60505-0355
11-Digit Billing Format
60505035500

Clinical Specifications

Proprietary Name
Chlorhexidine Gluconate
Dosage Form
-
Usage Information
This medication is used along with regular tooth brushing/flossing to treat gingivitis, a gum disease that causes red, swollen, and easily bleeding gums. Chlorhexidine belongs to a class of drugs known as antimicrobials. It works by decreasing the amount of bacteria in the mouth, helping to reduce swelling and redness of the gums and bleeding when you brush.

Regulatory & Marketing

Labeler Name
Apotex Corp
FDA Application #
ANDA075561
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-14-2000
End Marketing Date
10-10-2007
Listing Expiration
10-10-2007
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 60505-0355-0 identifies a specific commercial package of 475 ml in 1 bottle, plastic of Chlorhexidine Gluconate, labeled by Apotex Corp. 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 Apotex Corp on November 14, 2000. The current certification is valid through October 10, 2007.

What are the primary indications for this medication?

This medication is used along with regular tooth brushing/flossing to treat gingivitis, a gum disease that causes red, swollen, and easily bleeding gums. Chlorhexidine belongs to a class of drugs known as antimicrobials. It works by decreasing the amount of bacteria in the mouth, helping to reduce swelling and redness of the gums and bleeding when you brush.

How is this Apotex Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60505035500. 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)
60505-0355-0
11-Digit CMS (5-4-2)
60505-0355-00

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