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  5. NDC Package Code: 69367-310-56 Sodium Fluoride 1.1% Gel

NDC Package 69367-310-56 Sodium Fluoride 1.1% Gel

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:
69367-310-56
Package Description:
1 TUBE in 1 CARTON / 56 g in 1 TUBE
Product Code:
69367-310
Proprietary Name:
Sodium Fluoride 1.1% Gel
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 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 SF 1.1% Brush-On Gel 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 whether or not drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
11-Digit NDC Billing Format:
69367031056
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
56 GM
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:
    Westminster Pharmaceuticals, 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 5 mg/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:
    03-09-2021
    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 69367-310-56?

    The NDC Packaged Code 69367-310-56 is assigned to a package of 1 tube in 1 carton / 56 g in 1 tube of Sodium Fluoride 1.1% Gel, a human prescription drug labeled by Westminster Pharmaceuticals, Llc. The product's dosage form is gel and is administered via dental form.

    Is NDC 69367-310 included in the NDC Directory?

    Yes, Sodium Fluoride 1.1% Gel with product code 69367-310 is active and included in the NDC Directory. The product was first marketed by Westminster Pharmaceuticals, Llc on March 09, 2021 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 NDC billing unit for package 69367-310-56?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 56.

    What is the 11-digit format for NDC 69367-310-56?

    The 11-digit format is 69367031056. 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
    5-3-269367-310-565-4-269367-0310-56