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  5. NDC Package Code: 11527-704-42 Sodium Fluoride 5000 Ppm Sensitive

NDC Package 11527-704-42 Sodium Fluoride 5000 Ppm Sensitive

Sodium Fluoride1.1%,Potassium Nitrate 5% 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:
11527-704-42
Package Description:
1 TUBE in 1 CARTON / 100 mL in 1 TUBE
Product Code:
11527-704
Proprietary Name:
Sodium Fluoride 5000 Ppm Sensitive
Non-Proprietary Name:
Sodium Fluoride1.1%, Potassium Nitrate 5%
Substance Name:
Potassium Nitrate; Sodium Fluoride
Usage Information:
A dental caries preventive and sensitive toothpaste; for twice daily self-applied topical use,following by rinsing, helps reduce the painful sensitivity of the teeth to cold, heat, acid, sweets or contact in adults patients and children 12 years of age and older.  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 Sensitive 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze-tube is easily applied onto a toothbrush. This prescription toothpaste should be used twice 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:
11527070442
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type:
Human Prescription Drug
Labeler Name:
Sheffield Pharmaceuticals 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):
  • POTASSIUM NITRATE 57.5 mg/mL
  • SODIUM FLUORIDE 5.8 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:
    03-26-2020
    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 11527-704-42?

    The NDC Packaged Code 11527-704-42 is assigned to a package of 1 tube in 1 carton / 100 ml in 1 tube of Sodium Fluoride 5000 Ppm Sensitive, a human prescription drug labeled by Sheffield Pharmaceuticals Llc. The product's dosage form is gel, dentifrice and is administered via dental form.

    Is NDC 11527-704 included in the NDC Directory?

    Yes, Sodium Fluoride 5000 Ppm Sensitive with product code 11527-704 is active and included in the NDC Directory. The product was first marketed by Sheffield Pharmaceuticals Llc on March 26, 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 11527-704-42?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 11527-704-42?

    The 11-digit format is 11527070442. 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
    5-3-211527-704-425-4-211527-0704-42