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  5. NDC Package Code: 48783-500-40 Enamelon Preventive Treatment

NDC Package 48783-500-40 Enamelon Preventive Treatment

Stannous 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:
48783-500-40
Package Description:
1 TUBE in 1 CARTON / 113 g in 1 TUBE
Product Code:
48783-500
Proprietary Name:
Enamelon Preventive Treatment
Non-Proprietary Name:
Stannous Fluoride
Substance Name:
Stannous Fluoride
Usage Information:
Adults and children 6 years of age or older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not rinse, eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor.
11-Digit NDC Billing Format:
48783050040
NDC to RxNorm Crosswalk:
  • RxCUI: 237847 - stannous fluoride 0.4 % Oral Gel
  • RxCUI: 237847 - stannous fluoride 0.004 MG/MG Oral Gel
  • RxCUI: 237847 - stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral Gel
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Premier Dental Products Company
    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):
  • STANNOUS FLUORIDE .004 g/g
    • Sample Package:
    No
    FDA Application Number:
    part355
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    01-01-2014
    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 48783-500-40?

    The NDC Packaged Code 48783-500-40 is assigned to a package of 1 tube in 1 carton / 113 g in 1 tube of Enamelon Preventive Treatment, a human over the counter drug labeled by Premier Dental Products Company. The product's dosage form is gel and is administered via dental form.

    Is NDC 48783-500 included in the NDC Directory?

    Yes, Enamelon Preventive Treatment with product code 48783-500 is active and included in the NDC Directory. The product was first marketed by Premier Dental Products Company on January 01, 2014 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 48783-500-40?

    The 11-digit format is 48783050040. 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
    5-3-248783-500-405-4-248783-0500-40