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  5. NDC Package Code: 53045-275-10 Ionite H

NDC Package 53045-275-10 Ionite H

Stannous Fluoride Mouthwash 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:
53045-275-10
Package Description:
296 mL in 1 BOTTLE, DISPENSING
Product Code:
53045-275
Proprietary Name:
Ionite H
Non-Proprietary Name:
Stannous Fluoride
Substance Name:
Stannous Fluoride
Usage Information:
• Do not use before mixing with water• Adults and children 6 years of age and older:   - Use once per day after brushing your teeth with toothpaste   - Remove cap and replace with pump   - Rotate spout counter clockwise to extend   - Depress pump until rinse comes to the tip of the pump   - Pump 1/8 fl. oz. into a cup.   - Add water to the line (1 fl. oz.) on cup.   - Mix using bristle end of toothbrush   - Vigorously swish rinse between your teeth for 1 min. and then spit out.   - Do not swallow the rinse   - Do not eat or drink for 30 min. after rinsing   - Instruct children under 12 in good rinsing habits to minimize swallowing.   - Supervise children as necessary until capable of using without supervision• Children under 6: Consult a dentist or doctor
11-Digit NDC Billing Format:
53045027510
NDC to RxNorm Crosswalk:
  • RxCUI: 583459 - stannous fluoride 0.63 % Dental Solution
  • RxCUI: 583459 - stannous fluoride 6.3 MG/ML Mouthwash
  • RxCUI: 583459 - stannous fluoride 0.63 % (fluoride ion 0.12 % ) Dental Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Dharma Research, Inc.
    Dosage Form:
    Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
    Administration Route(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • STANNOUS FLUORIDE .63 mg/100mL
    • Sample Package:
    No
    FDA Application Number:
    M021
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    08-03-2015
    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.

    Frequently Asked Questions

    What is NDC 53045-275-10?

    The NDC Packaged Code 53045-275-10 is assigned to a package of 296 ml in 1 bottle, dispensing of Ionite H, a human over the counter drug labeled by Dharma Research, Inc.. The product's dosage form is mouthwash and is administered via dental form.

    Is NDC 53045-275 included in the NDC Directory?

    Yes, Ionite H with product code 53045-275 is active and included in the NDC Directory. The product was first marketed by Dharma Research, Inc. on August 03, 2015 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 11-digit format for NDC 53045-275-10?

    The 11-digit format is 53045027510. 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
    5-3-253045-275-105-4-253045-0275-10