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  5. NDC Package Code: 25047-773-16 Kolorz Sixty Second Fluoride Cotton Candy

NDC Package 25047-773-16 Kolorz Sixty Second Fluoride Cotton Candy

Sodium Fluoride Gel 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:
25047-773-16
Package Description:
480 mL in 1 BOTTLE
Product Code:
25047-773
Proprietary Name:
Kolorz Sixty Second Fluoride Cotton Candy
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
Usage Information:
For topical application of fluoride to aid in the protection against dental caries.
11-Digit NDC Billing Format:
25047077316
NDC to RxNorm Crosswalk:
  • RxCUI: 1535362 - sodium fluoride 2.72 % Oral Gel
  • RxCUI: 1535362 - sodium fluoride 0.0272 MG/MG Oral Gel
  • RxCUI: 1535362 - sodium fluoride 2.7 % Oral Gel
  • RxCUI: 1535362 - sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral Gel
  • RxCUI: 2121950 - Kolorz Sixty Second Fluoride 2.72 % Oral Gel
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Dmg America, Llc
    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.
    • Active Ingredient(s):
  • SODIUM FLUORIDE 12.3 mg/mL
    • 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:
    11-22-2006
    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 25047-773-16?

    The NDC Packaged Code 25047-773-16 is assigned to a package of 480 ml in 1 bottle of Kolorz Sixty Second Fluoride Cotton Candy, a human prescription drug labeled by Dmg America, Llc. The product's dosage form is gel and is administered via dental form.

    Is NDC 25047-773 included in the NDC Directory?

    Yes, Kolorz Sixty Second Fluoride Cotton Candy with product code 25047-773 is active and included in the NDC Directory. The product was first marketed by Dmg America, Llc on November 22, 2006 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 25047-773-16?

    The 11-digit format is 25047077316. 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
    5-3-225047-773-165-4-225047-0773-16