Burkhart Concentrate
NDC Package 43498-201-10

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

Package Information

Burkhart (stannous fluoride) concentrates is aids in the prevention of dental decay. This formulation utilizes a concentrate delivery system. Marketed by Burkhart Dental Supply Inc, this product is identified by NDC 43498-201.

Identification & Billing

NDC Package Code
43498-201-10
Package Description
284 g in 1 BOTTLE, PLASTIC
Product Code
43498-201
11-Digit Billing Format
43498020110
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Burkhart
Non-Proprietary Name
Stannous Fluoride
Substance Name
Stannous Fluoride
Dosage Form
Concentrate - A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
STANNOUS FLUORIDE .3408 g/284g
Usage Information
Aids in the prevention of dental decay. Helps prevent gingivitis. Helps control plaque bacteria. Increases protection against painful tooth sensitivity. This product mist be used under the supervision of a dentist.

Regulatory & Marketing

Labeler Name
Burkhart Dental Supply 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
02-01-2013
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 43498-201-10 identifies a specific commercial package of 284 g in 1 bottle, plastic of Burkhart, a human prescription drug labeled by Burkhart Dental Supply Inc. This concentrate is formulated for dental 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 Burkhart Dental Supply Inc on February 01, 2013. The current certification is valid through December 31, 2026.

How is this Burkhart Dental Supply Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43498020110. 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)
43498-201-10
11-Digit CMS (5-4-2)
43498-0201-10

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