Ludent
NDC Package 44946-1017-2

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

Package Information

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

Ludent is for once daily self-applied systemic use as a dental caries preventive in pediatric patients. Marketed by Sancilio & Company Inc, this product is identified by NDC 44946-1017.

Identification & Billing

NDC Package Code
44946-1017-2
Package Description
60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Product Code
44946-1017
11-Digit Billing Format
44946101702
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ludent
Dosage Form
-
Usage Information
For once daily self-applied systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F¯) during the period of tooth development results in a significant decrease in the incidence of dental caries. Sodium Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from age 3 years to age 16 years and older living in areas where the drinking water fluoride contents does not exceed 0.6 ppm F¯.

Regulatory & Marketing

Labeler Name
Sancilio & Company Inc
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
09-10-2009
Listing Expiration
12-31-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (44946-1017). Click a package code to view its specific billing and regulatory data.

44946-1017-3
120 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
44946-1017-6
30 TABLET, CHEWABLE in 1 BLISTER PACK

* 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 44946-1017-2 identifies a specific commercial package of 60 tablet, chewable in 1 bottle, plastic of Ludent, labeled by Sancilio & Company 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 Sancilio & Company Inc on September 10, 2009. The current certification is valid through December 31, 2017.

How is this Sancilio & Company Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 44946101702. 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)
44946-1017-2
11-Digit CMS (5-4-2)
44946-1017-02

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