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  5. NDC Package Code: 35573-434-51 Sodium Fluoride 5000 Ppm

NDC Package 35573-434-51 Sodium Fluoride 5000 Ppm

Sodium Fluoride Paste, 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:
35573-434-51
Package Description:
1 TUBE in 1 CARTON / 51 g in 1 TUBE
Product Code:
35573-434
Proprietary Name:
Sodium Fluoride 5000 Ppm
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 Sodium Fluoride 5000 ppm dental cream 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your 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:
35573043451
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
51 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:
    Burel Pharmaceuticals Llc
    Dosage Form:
    Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
    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:
    02-28-2020
    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 35573-434-51?

    The NDC Packaged Code 35573-434-51 is assigned to a package of 1 tube in 1 carton / 51 g in 1 tube of Sodium Fluoride 5000 Ppm, a human prescription drug labeled by Burel Pharmaceuticals Llc. The product's dosage form is paste, dentifrice and is administered via dental form.

    Is NDC 35573-434 included in the NDC Directory?

    Yes, Sodium Fluoride 5000 Ppm with product code 35573-434 is active and included in the NDC Directory. The product was first marketed by Burel Pharmaceuticals Llc on February 28, 2020 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 35573-434-51?

    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 51.

    What is the 11-digit format for NDC 35573-434-51?

    The 11-digit format is 35573043451. 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
    5-3-235573-434-515-4-235573-0434-51