NDC Package 0116-2001-15 Chlorhexidine Gluconate

Rinse Oral - View Billable Units, 11-Digit Format, RxNorm

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:
0116-2001-15
Package Description:
15 mL in 1 BOTTLE
Product Code:
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:
00116200115
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
15 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 834127 - chlorhexidine gluconate 0.12 % Oral Rinse
  • RxCUI: 834127 - chlorhexidine gluconate 1.2 MG/ML Mouthwash
  • RxCUI: 834127 - chlorhexidine gluconate 0.12 % Mouthwash
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Xttrium Laboratories, Inc.
    Dosage Form:
    Rinse - A liquid used to cleanse by flushing.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA077789
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-01-2010
    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
    0116-2001-04118 mL in 1 BOTTLE
    0116-2001-0515 mL in 1 CUP, UNIT-DOSE
    0116-2001-06600 mL in 1 CASE
    0116-2001-071500 mL in 1 CASE
    0116-2001-16473 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0116-2001-15?

    The NDC Packaged Code 0116-2001-15 is assigned to a package of 15 ml in 1 bottle of Chlorhexidine Gluconate, a human prescription drug labeled by Xttrium Laboratories, Inc.. The product's dosage form is rinse and is administered via oral form.

    Is NDC 0116-2001 included in the NDC Directory?

    Yes, Chlorhexidine Gluconate with product code 0116-2001 is active and included in the NDC Directory. The product was first marketed by Xttrium Laboratories, Inc. on June 01, 2010 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 0116-2001-15?

    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 15.

    What is the 11-digit format for NDC 0116-2001-15?

    The 11-digit format is 00116200115. 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 4-4-2 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
    4-4-20116-2001-155-4-200116-2001-15