Chlorhexidine Gluconate 0.12% Oral Rinse Liquid
NDC Package 53462-003-15

11-digit billing NDC: 53462000315
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Chlorhexidine Gluconate 0.12% Oral Rinse (chlorhexidine gluconate) liquids is 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. This formulation utilizes a liquid delivery system. Marketed by Sage Products Llc, this product is identified by NDC 53462-003 and is authorized under FDA application ANDA077789.

Identification & Billing

NDC Package Code
53462-003-15
Package Description
15 mL in 1 BOTTLE
Product Code
53462-003
11-Digit Billing Format
53462000315
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Chlorhexidine Gluconate 0.12% Oral Rinse
Non-Proprietary Name
Chlorhexidine Gluconate
Substance Name
Chlorhexidine Gluconate
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.
Administration Route
Buccal - Administration directed toward the cheek, generally from within the mouth.
Active Ingredient(s)
CHLORHEXIDINE GLUCONATE 1.2 mg/mL
Pharmacologic Class
Decreased Cell Wall Integrity - [PE] (Physiologic Effect)
Usage Information
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
Sage Products Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA077789
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-20-2014
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53462-003-15 identifies a specific commercial package of 15 ml in 1 bottle of Chlorhexidine Gluconate 0.12% Oral Rinse, a human prescription drug labeled by Sage Products Llc. This liquid is formulated for buccal 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 Sage Products Llc on January 20, 2014. The current certification is valid through December 31, 2026.

How is this Sage Products Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53462000315. 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)
53462-003-15
11-Digit CMS (5-4-2)
53462-0003-15

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