Amerfresh Fluoride
NDC Package 51460-3002-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Amerfresh Fluoride is adults and children 2 yrs. Marketed by Amercare Products, Inc., this product is identified by NDC 51460-3002 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
51460-3002-1
Package Description
17 g in 1 TUBE
Product Code
51460-3002
11-Digit Billing Format
51460300201

Clinical Specifications

Proprietary Name
Amerfresh Fluoride
Dosage Form
-
Usage Information
Adults and children 2 yrs. and older: Brush teeth throughtly after meals or at least twice a day or as directed by a dentist. Do not swallowTo minimize swallowing, use a pea-sized amount in children under 6 years old. Supervise children's brushing until good habits are established. Children under 2 yrs.: ask a dentist before use.

Regulatory & Marketing

Labeler Name
Amercare Products, Inc.
FDA Application #
part355
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
09-12-2016
Listing Expiration
12-31-2019
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51460-3002-1 identifies a specific commercial package of 17 g in 1 tube of Amerfresh Fluoride, labeled by Amercare Products, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Amercare Products, Inc. on September 12, 2016. The current certification is valid through December 31, 2019.

How is this Amercare Products, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51460300201. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
51460-3002-1
11-Digit CMS (5-4-2)
51460-3002-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.