Chlorhexidine Gluconate 20% Solution Liquid
NDC Package 0116-0100-55

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 20% Solution liquids is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a liquid delivery system. Marketed by Xttrium Laboratories, Inc., this product is identified by NDC 0116-0100.

Identification & Billing

NDC Package Code
0116-0100-55
Package Description
213000 g in 1 DRUM
Product Code
0116-0100
11-Digit Billing Format
00116010055

Clinical Specifications

Proprietary Name
Chlorhexidine Gluconate 20% Solution
Non-Proprietary Name
Chlorhexidine Gluconate 20% Solution
Substance Name
Chlorhexidine
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Active Ingredient(s)
CHLORHEXIDINE 20 g/20g

Regulatory & Marketing

Labeler Name
Xttrium Laboratories, Inc.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-01-1985
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 (0116-0100). Click a package code to view its specific billing and regulatory data.

0116-0100-75
1040000 g 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 0116-0100-55 identifies a specific commercial package of 213000 g in 1 drum of Chlorhexidine Gluconate 20% Solution (UNFINISHED drug), a bulk ingredient labeled by Xttrium Laboratories, Inc.. This liquid 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 Xttrium Laboratories, Inc. on January 01, 1985. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00116010055. 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)
0116-0100-55
11-Digit CMS (5-4-2)
00116-0100-55

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