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  5. NDC Package Code: 61578-216-01 Pro Gel 5000 Citrus

NDC Package 61578-216-01 Pro Gel 5000 Citrus

Sodium 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:
61578-216-01
Package Description:
68 g in 1 TUBE, WITH APPLICATOR
Product Code:
61578-216
Proprietary Name:
Pro Gel 5000 Citrus
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
Usage Information:
A dental caries preventive; for once daily self-applied topical use. It is well established that a 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 CariFree CTx4 Gel 5000 brand of 1.1% sodium fluoride toothpaste in a squeeze tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use of a regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See Warnings for exception)
11-Digit NDC Billing Format:
61578021601
NDC to RxNorm Crosswalk:
  • RxCUI: 392038 - sodium fluoride 1.1 % Toothpaste
  • RxCUI: 392038 - sodium fluoride 0.011 MG/MG Toothpaste
  • RxCUI: 392038 - sodium fluoride 1.1 % (fluoride ion 0.5 % ) Toothpaste
  • RxCUI: 392038 - sodium fluoride 1.1 % Dental Gel
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Dental Alliance Holdings Llc
    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):
  • SODIUM FLUORIDE 5000 ug/g
    • 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:
    05-10-2022
    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 61578-216-01?

    The NDC Packaged Code 61578-216-01 is assigned to a package of 68 g in 1 tube, with applicator of Pro Gel 5000 Citrus, a human prescription drug labeled by Dental Alliance Holdings Llc. The product's dosage form is gel, dentifrice and is administered via dental form.

    Is NDC 61578-216 included in the NDC Directory?

    Yes, Pro Gel 5000 Citrus with product code 61578-216 is active and included in the NDC Directory. The product was first marketed by Dental Alliance Holdings Llc on May 10, 2022 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 61578-216-01?

    The 11-digit format is 61578021601. 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
    5-3-261578-216-015-4-261578-0216-01