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  5. NDC Package Code: 51206-313-02 Opal By Opalescence Complete

NDC Package 51206-313-02 Opal By Opalescence Complete

Gel, Dentifrice Dental - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
51206-313-02
Package Description:
12 CARTON in 1 PACKAGE, COMBINATION / 1 TUBE in 1 CARTON / 133 g in 1 TUBE
Product Code:
51206-313
Proprietary Name:
Opal By Opalescence Complete
Non-Proprietary Name:
Opal By Opalescence Complete
Substance Name:
Stannous Fluoride
11-Digit NDC Billing Format:
51206031302
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:
Ultradent Products, Inc.
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):
STANNOUS FLUORIDE 1.1 mg/g
Sample Package:
No
FDA Application Number:
M021
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
10-21-2024
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.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
51206-313-011 TUBE in 1 CARTON / 133 g in 1 TUBE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 51206-313-02?

The NDC Packaged Code 51206-313-02 is assigned to a package of 12 carton in 1 package, combination / 1 tube in 1 carton / 133 g in 1 tube of Opal By Opalescence Complete, a human over the counter drug labeled by Ultradent Products, Inc.. The product's dosage form is gel, dentifrice and is administered via dental form.

Is NDC 51206-313 included in the NDC Directory?

Yes, Opal By Opalescence Complete with product code 51206-313 is active and included in the NDC Directory. The product was first marketed by Ultradent Products, Inc. on October 21, 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 51206-313-02?

The 11-digit format is 51206031302. 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
5-3-251206-313-025-4-251206-0313-02