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  5. NDC Package Code: 53045-270-04 Ionite H

NDC Package 53045-270-04 Ionite H

Stannous Fluoride Gel, Dentifrice 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:
53045-270-04
Package Description:
122 g in 1 TUBE
Product Code:
53045-270
Proprietary Name:
Ionite H
Non-Proprietary Name:
Stannous Fluoride
Substance Name:
Stannous Fluoride
Usage Information:
• This is not a toothpaste. Read directions carefully before using.• Adults and children 6 years of age and older:   o Use once per day after brushing teeth thoroughly with toothpaste   o Twist off cap to remove foil seal   o Apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces.   o Allow the gel to remain on your teeth for 1 minute   o Spit out. Do not swallow   o Do not eat, drink, or rinse for at least 30 minutes• Children under 6: consult a dentist or doctor
11-Digit NDC Billing Format:
53045027004
NDC to RxNorm Crosswalk:
  • RxCUI: 237847 - stannous fluoride 0.4 % Oral Gel
  • RxCUI: 237847 - stannous fluoride 0.004 MG/MG Oral Gel
  • RxCUI: 237847 - stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral Gel
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Dharma Research, Inc.
    Dosage Form:
    Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.
    Administration Route(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • STANNOUS FLUORIDE .4 mg/100g
    • Sample Package:
    No
    FDA Application Number:
    M021
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    08-02-2015
    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 53045-270-04?

    The NDC Packaged Code 53045-270-04 is assigned to a package of 122 g in 1 tube of Ionite H, a human over the counter drug labeled by Dharma Research, Inc.. The product's dosage form is gel, dentifrice and is administered via dental form.

    Is NDC 53045-270 included in the NDC Directory?

    Yes, Ionite H with product code 53045-270 is active and included in the NDC Directory. The product was first marketed by Dharma Research, Inc. on August 02, 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 53045-270-04?

    The 11-digit format is 53045027004. 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
    5-3-253045-270-045-4-253045-0270-04