Chlorhexidine Gluconate Rinse
NDC Package 0116-2001-06

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

Chlorhexidine Gluconate rinses is a medication used along with regular tooth brushing/flossing to treat gingivitis, a gum disease that causes red, swollen, and easily bleeding gums. This formulation utilizes a rinse delivery system. Marketed by Xttrium Laboratories, Inc., this product is identified by NDC 0116-2001 and is authorized under FDA application ANDA077789.

Identification & Billing

NDC Package Code
0116-2001-06
Package Description
600 mL in 1 CASE
Product Code
0116-2001
11-Digit Billing Format
00116200106
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
600 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Chlorhexidine Gluconate
Non-Proprietary Name
Chlorhexidine Gluconate
Substance Name
Chlorhexidine Gluconate
Dosage Form
Rinse - A liquid used to cleanse by flushing.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CHLORHEXIDINE GLUCONATE 1.2 mg/mL
Pharmacologic Class
Decreased Cell Wall Integrity - [PE] (Physiologic Effect)
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
Xttrium Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA077789
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2010
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 (0116-2001). Click a package code to view its specific billing and regulatory data.

0116-2001-04
118 mL in 1 BOTTLE
0116-2001-05
15 mL in 1 CUP, UNIT-DOSE
0116-2001-07
1500 mL in 1 CASE
0116-2001-15
15 mL in 1 BOTTLE
0116-2001-16
473 mL 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 0116-2001-06 identifies a specific commercial package of 600 ml in 1 case of Chlorhexidine Gluconate, a human prescription drug labeled by Xttrium Laboratories, Inc.. This rinse is formulated for oral use and contains chlorhexidine gluconate 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 Xttrium Laboratories, Inc. on June 01, 2010. The current certification is valid through December 31, 2026.

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 Xttrium Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00116200106. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 600 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 (4-4-2)
0116-2001-06
11-Digit CMS (5-4-2)
00116-2001-06

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