1. Home
  2. Labeler Index
  3. Fulijaya Manufacturing Sdn. Bhd
  4. 62776-003
  5. NDC Package Code: 62776-003-01 Made By Dentists Enamel Rebuilding Professional

NDC Package 62776-003-01 Made By Dentists Enamel Rebuilding Professional

Potassium Nitrate,Sodium Fluoride Paste 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:
62776-003-01
Package Description:
1 TUBE in 1 CARTON / 120 g in 1 TUBE
Product Code:
62776-003
Proprietary Name:
Made By Dentists Enamel Rebuilding Professional
Non-Proprietary Name:
Potassium Nitrate, Sodium Fluoride
Substance Name:
Potassium Nitrate; Sodium Fluoride
Usage Information:
Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly, for at least 1 minute twice a day, (morning and evening) or as recommended by a dentist or doctor.Make sure to brush all sensitive areas of the teeth.Children under 12 years of age: Consult a dentist or doctor.
11-Digit NDC Billing Format:
62776000301
NDC to RxNorm Crosswalk:
  • RxCUI: 1038929 - potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste
  • RxCUI: 1038929 - potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste
  • RxCUI: 1038929 - K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste
  • RxCUI: 1038929 - Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste
  • RxCUI: 1038929 - potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste
Product Type:
Human Otc Drug
Labeler Name:
Fulijaya Manufacturing Sdn. Bhd
Dosage Form:
Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s):
Dental - Administration to a tooth or teeth.
Active Ingredient(s):
Sample Package:
No
FDA Application Number:
M022
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
01-01-2024
Listing Expiration Date:
12-31-2026
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 62776-003-01?

The NDC Packaged Code 62776-003-01 is assigned to a package of 1 tube in 1 carton / 120 g in 1 tube of Made By Dentists Enamel Rebuilding Professional, a human over the counter drug labeled by Fulijaya Manufacturing Sdn. Bhd. The product's dosage form is paste and is administered via dental form.

Is NDC 62776-003 included in the NDC Directory?

Yes, Made By Dentists Enamel Rebuilding Professional with product code 62776-003 is active and included in the NDC Directory. The product was first marketed by Fulijaya Manufacturing Sdn. Bhd on January 01, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 62776-003-01?

The 11-digit format is 62776000301. 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
5-3-262776-003-015-4-262776-0003-01