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  5. NDC Package Code: 48783-520-43 Enamelon

NDC Package 48783-520-43 Enamelon

Stannous 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:
48783-520-43
Package Description:
1 TUBE in 1 CARTON / 122 g in 1 TUBE
Product Code:
48783-520
Proprietary Name:
Enamelon
Non-Proprietary Name:
Stannous Fluoride
Substance Name:
Stannous Fluoride
Usage Information:
Adults and children 2 years of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.
11-Digit NDC Billing Format:
48783052043
NDC to RxNorm Crosswalk:
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.00454 MG/MG Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste
Product Type:
Human Otc Drug
Labeler Name:
Premier Dental Products Company
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):
STANNOUS FLUORIDE .00454 g/g
Sample Package:
No
FDA Application Number:
M021
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
01-01-2014
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 48783-520-43?

The NDC Packaged Code 48783-520-43 is assigned to a package of 1 tube in 1 carton / 122 g in 1 tube of Enamelon, a human over the counter drug labeled by Premier Dental Products Company. The product's dosage form is paste, dentifrice and is administered via dental form.

Is NDC 48783-520 included in the NDC Directory?

Yes, Enamelon with product code 48783-520 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, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 48783-520-43?

The 11-digit format is 48783052043. 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
5-3-248783-520-435-4-248783-0520-43