NDC Package 70766-004-01 Amerfresh Tooth

Sodium Fluoride Powder Dental - View Billable Units, 11-Digit Format, RxNorm

Package Information
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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:

70766-004-01

Package Description:

40 PACKAGE in 1 CARTON / 454 g in 1 PACKAGE

Product Code:

70766-004

Proprietary Name:

Amerfresh Tooth

Non-Proprietary Name:

Sodium Fluoride

Substance Name:

Sodium Fluoride

Usage Information:

For Use:Wet toothbrush and dip into powder until brush is fully covereddo not swallow .supervise children as necessary until capable of useing without supervisioninstruct children under 12 years of age in good brushing and rinsing habits(to minimize swallowing).Adults and children 6 years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.Children under 6 years of age:do not use unless directed by a doctor or dentist.

11-Digit NDC Billing Format:

70766000401

Product Type:

Human Otc Drug

Labeler Name:

Yangzhou Sion Commodity Co.,ltd

Dosage Form:

Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

Administration Route(s):

Dental - Administration to a tooth or teeth.

Active Ingredient(s):

SODIUM FLUORIDE .1 g/100g

Sample Package:

FDA Application Number:

part356

Marketing Category:

OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.

Start Marketing Date:

04-20-2018

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

70766 - Yangzhou Sion Commodity Co.,ltd
- 70766-004 - Amerfresh Tooth
  - 70766-004-01 - 40 PACKAGE in 1 CARTON / 454 g in 1 PACKAGE

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 Code	Package Description
70766-004-02	4 BOX in 1 CARTON / 50 POUCH in 1 BOX / 57 g in 1 POUCH

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 70766-004-01?

The NDC Packaged Code 70766-004-01 is assigned to a package of 40 package in 1 carton / 454 g in 1 package of Amerfresh Tooth, a human over the counter drug labeled by Yangzhou Sion Commodity Co.,ltd. The product's dosage form is powder and is administered via dental form.

Is NDC 70766-004 included in the NDC Directory?

Yes, Amerfresh Tooth with product code 70766-004 is active and included in the NDC Directory. The product was first marketed by Yangzhou Sion Commodity Co.,ltd on April 20, 2018 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 70766-004-01?

The 11-digit format is 70766000401. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	70766-004-01	5-4-2	70766-0004-01

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