Denti-care Denti-rinse
NDC Package 0116-0244-01

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.

Denti-care Denti-rinse is iNDICATION: Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Marketed by Xttrium Laboratories, Inc., this product is identified by NDC 0116-0244 and is authorized under FDA application ANDA077789.

Identification & Billing

NDC Package Code
0116-0244-01
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
0116-0244
11-Digit Billing Format
00116024401

Clinical Specifications

Proprietary Name
Denti-care Denti-rinse Chlorhexidine Gluconate Oral Rinse
Dosage Form
-
Usage Information
INDICATION: Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis; see PRECAUTIONS.

Regulatory & Marketing

Labeler Name
Xttrium Laboratories, Inc.
FDA Application #
ANDA077789
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-02-2006
End Marketing Date
05-31-2023
Listing Expiration
05-31-2023
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 0116-0244-01 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Denti-care Denti-rinse Chlorhexidine Gluconate Oral Rinse, labeled by Xttrium Laboratories, 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 Xttrium Laboratories, Inc. on June 02, 2006. The current certification is valid through May 31, 2023.

How is this Xttrium Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00116024401. 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 (4-4-2)
0116-0244-01
11-Digit CMS (5-4-2)
00116-0244-01

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