1. Home
  2. Labeler Index
  3. Dharma Research, Inc.
  4. 53045-200
  5. NDC Package Code: 53045-200-17 Ionite Apf

NDC Package 53045-200-17 Ionite Apf

Sodium Fluoride Gel Dental; Oral - 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:
53045-200-17
Package Description:
490 g in 1 BOTTLE
Product Code:
53045-200
Proprietary Name:
Ionite Apf
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
11-Digit NDC Billing Format:
53045020017
NDC to RxNorm Crosswalk:
  • RxCUI: 245593 - sodium fluoride 2 % Dental Gel
  • RxCUI: 245593 - sodium fluoride 0.02 MG/MG Oral Gel
  • RxCUI: 245593 - sodium fluoride 2 % (fluoride ion 1.23 % ) Dental Gel
  • RxCUI: 245593 - sodium fluoride 2.09 % (fluoride ion 1.23 % ) Dental Gel
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Dharma Research, Inc.
    Dosage Form:
    Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
    Administration Route(s):
  • Dental - Administration to a tooth or teeth.
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SODIUM FLUORIDE 10.241 g/490g
    • 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:
    01-01-2013
    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
    53045-200-08245 g in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53045-200-17?

    The NDC Packaged Code 53045-200-17 is assigned to a package of 490 g in 1 bottle of Ionite Apf, a human prescription drug labeled by Dharma Research, Inc.. The product's dosage form is gel and is administered via dental; oral form.

    Is NDC 53045-200 included in the NDC Directory?

    Yes, Ionite Apf with product code 53045-200 is active and included in the NDC Directory. The product was first marketed by Dharma Research, Inc. on January 01, 2013 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 53045-200-17?

    The 11-digit format is 53045020017. 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
    5-3-253045-200-175-4-253045-0200-17