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  5. NDC Package Code: 16571-111-48 Chlorhexidine Gluconate

NDC Package 16571-111-48 Chlorhexidine Gluconate

Solution Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
16571-111-48
Package Description:
473 mL in 1 BOTTLE
Product Code:
16571-111
Proprietary Name:
Chlorhexidine Gluconate
Non-Proprietary Name:
Chlorhexidine Gluconate
Substance Name:
Chlorhexidine Gluconate
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.
11-Digit NDC Billing Format:
16571011148
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
473 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 211365 - chlorhexidine gluconate 4 % Medicated Liquid Soap
  • RxCUI: 211365 - chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap
  • RxCUI: 211365 - chlorhexidine gluconate 4 % Medicated Surgical Scrub
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Rising Pharma Holdings, Inc.
    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.
    Administration Route(s):
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Active Ingredient(s):
  • CHLORHEXIDINE GLUCONATE 40 mg/mL
    • Pharmacologic Class(es):
  • Decreased Cell Wall Integrity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    NDA019258
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-26-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    16571-111-12118 mL in 1 BOTTLE
    16571-111-24237 mL in 1 BOTTLE
    16571-111-95946 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 16571-111-48?

    The NDC Packaged Code 16571-111-48 is assigned to a package of 473 ml in 1 bottle of Chlorhexidine Gluconate, a human over the counter drug labeled by Rising Pharma Holdings, Inc.. The product's dosage form is solution and is administered via topical form.

    Is NDC 16571-111 included in the NDC Directory?

    Yes, Chlorhexidine Gluconate with product code 16571-111 is active and included in the NDC Directory. The product was first marketed by Rising Pharma Holdings, Inc. on July 26, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 16571-111-48?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 473.

    What is the 11-digit format for NDC 16571-111-48?

    The 11-digit format is 16571011148. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-216571-111-485-4-216571-0111-48