Stannous Fluoride Crystal
NDC Package 58110-007-03

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Stannous Fluoride crystals is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a crystal delivery system. Marketed by Stella Chemifa Corporation, this product is identified by NDC 58110-007.

Identification & Billing

NDC Package Code
58110-007-03
Package Description
23 kg in 1 DRUM
Product Code
58110-007
11-Digit Billing Format
58110000703

Clinical Specifications

Proprietary Name
Stannous Fluoride
Non-Proprietary Name
Stannous Fluoride
Substance Name
Stannous Fluoride
Dosage Form
Crystal - A naturally produced angular solid of definite form in which the ultimate units from which it is built up are systematically arranged; they are usually evenly spaced on a regular space lattice.
Active Ingredient(s)
STANNOUS FLUORIDE 100 kg/100kg

Regulatory & Marketing

Labeler Name
Stella Chemifa Corporation
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
12-02-2015
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 58110-007-03 identifies a specific commercial package of 23 kg in 1 drum of Stannous Fluoride (UNFINISHED drug), a bulk ingredient labeled by Stella Chemifa Corporation. This crystal is formulated for use and contains stannous 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 Stella Chemifa Corporation on December 02, 2015. The current certification is valid through December 31, 2026.

How is this Stella Chemifa Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58110000703. 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)
58110-007-03
11-Digit CMS (5-4-2)
58110-0007-03

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