Chlorhexidine Gluconate Solution
NDC Package 42939-101-04

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Chlorhexidine Gluconate solution 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 solution delivery system. Marketed by Ava, Inc., this product is identified by NDC 42939-101.

Identification & Billing

NDC Package Code
42939-101-04
Package Description
1040988 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
Product Code
42939-101
11-Digit Billing Format
42939010104

Clinical Specifications

Proprietary Name
Chlorhexidine Gluconate
Non-Proprietary Name
Chlorhexidine Gluconate
Substance Name
Chlorhexidine
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Active Ingredient(s)
CHLORHEXIDINE 20 mg/mL
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
Ava, Inc.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
07-05-2010
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (42939-101). Click a package code to view its specific billing and regulatory data.

42939-101-01
18927 mL in 1 CONTAINER
42939-101-02
500 mL in 1 DRUM
42939-101-03
208198 mL in 1 DRUM

* 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 42939-101-04 identifies a specific commercial package of 1040988 ml in 1 container, flexible intermediate bulk of Chlorhexidine Gluconate (UNFINISHED drug), a bulk ingredient labeled by Ava, Inc.. This solution is formulated for use and contains chlorhexidine 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 Ava, Inc. on July 05, 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 Ava, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42939010104. 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)
42939-101-04
11-Digit CMS (5-4-2)
42939-0101-04

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