Neutral Sodium Fluoride
NDC Package 44946-1050-0

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.

Neutral Sodium Fluoride is for once weekly use as a dental caries preventative in pediatric patients. Marketed by Sancilio & Company Inc, this product is identified by NDC 44946-1050.

Identification & Billing

NDC Package Code
44946-1050-0
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
44946-1050
11-Digit Billing Format
44946105000

Clinical Specifications

Proprietary Name
Neutral Sodium Fluoride
Dosage Form
-
Usage Information
For once weekly use as a dental caries preventative in pediatric patients.

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
01-01-2013
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 44946-1050-0 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Neutral Sodium Fluoride, 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 January 01, 2013. 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: 44946105000. 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)
44946-1050-0
11-Digit CMS (5-4-2)
44946-1050-00

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