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  5. NDC Package Code: 68400-202-10 Gelato Perio Maintenance Rinse

NDC Package 68400-202-10 Gelato Perio Maintenance Rinse

Stannous Fluoride Concentrate Dental - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
68400-202-10
Package Description:
283.5 g in 1 BOTTLE, PLASTIC
Product Code:
68400-202
Proprietary Name:
Gelato Perio Maintenance Rinse
Non-Proprietary Name:
Stannous Fluoride
Substance Name:
Stannous Fluoride
Usage Information:
Adults and children 6 years of age and older:Do not use before mixing with water. Use immediately after preparing the rinse. Remove cap and replace with pump.Rotate spout container clockwise to extend. Depress pump until rinse comes to the tip of the pump. Depress pump twice into cup provided (1/8oz). Add water to line (1oz) on cup. Mix well.Vigorously swish rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age:Consult a dentist or doctor.
11-Digit NDC Billing Format:
68400020210
NDC to RxNorm Crosswalk:
  • RxCUI: 1435516 - Gelato Perio Rinse 0.63 % (fluoride ion 0.12 % ) Dental Solution
  • RxCUI: 1435516 - stannous fluoride 6.3 MG/ML Mouthwash [Gelato Perio Rinse]
  • RxCUI: 1435516 - Gelato Perio Rinse 0.63 % (fluoride ion 0.12 % ) Mouthwash
  • RxCUI: 1435516 - Gelato Perio Rinse 6.3 MG/ML Mouthwash
  • RxCUI: 583459 - stannous fluoride 0.63 % Dental Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.
    Dosage Form:
    Concentrate - A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration.
    Administration Route(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • STANNOUS FLUORIDE .34 g/283.5g
    • Sample Package:
    No
    Marketing Category:
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date:
    02-01-2013
    Listing Expiration Date:
    12-31-2025
    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.

    Frequently Asked Questions

    What is NDC 68400-202-10?

    The NDC Packaged Code 68400-202-10 is assigned to a package of 283.5 g in 1 bottle, plastic of Gelato Perio Maintenance Rinse, a human prescription drug labeled by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.. The product's dosage form is concentrate and is administered via dental form.

    Is NDC 68400-202 included in the NDC Directory?

    Yes, Gelato Perio Maintenance Rinse with product code 68400-202 is active and included in the NDC Directory. The product was first marketed by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc. on February 01, 2013 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 68400-202-10?

    The 11-digit format is 68400020210. 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
    5-3-268400-202-105-4-268400-0202-10