Gelato Apf Gel
NDC Package 68400-313-15

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

Package Information

Gelato Apf (sodium fluoride) gel is a stable thixotropic fluoride treatment gel used to help prevent dental decay.For professional office use only. This formulation utilizes a gel delivery system. Marketed by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc., this product is identified by NDC 68400-313.

Identification & Billing

NDC Package Code
68400-313-15
Package Description
454 g in 1 BOTTLE, PLASTIC
Product Code
68400-313
11-Digit Billing Format
68400031315
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gelato Apf
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE 5.6 g/454g
Usage Information
A stable thixotropic fluoride treatment gel used to help prevent dental decay.For professional office use only. This product is not intended for home or unsupervised consumer use.

Regulatory & Marketing

Labeler Name
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
04-01-2014
Listing Expiration
12-31-2026
Exclude Flag
N
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 68400-313-15 identifies a specific commercial package of 454 g in 1 bottle, plastic of Gelato Apf, a human prescription drug labeled by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.. This gel is formulated for dental use and contains sodium fluoride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc. on April 01, 2014. The current certification is valid through December 31, 2026.

How is this Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68400031315. 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 (5-3-2)
68400-313-15
11-Digit CMS (5-4-2)
68400-0313-15

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