Topex
NDC Package 10216-3071-1

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.

Topex is indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Marketed by Dentsply Caulk, this product is identified by NDC 10216-3071.

Identification & Billing

NDC Package Code
10216-3071-1
Package Description
100 g in 1 JAR
Product Code
10216-3071
11-Digit Billing Format
10216307101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Topex Cherry
Dosage Form
-
Usage Information
Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intraoral radiographs.

Regulatory & Marketing

Labeler Name
Dentsply Caulk
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
02-19-1963
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 10216-3071-1 identifies a specific commercial package of 100 g in 1 jar of Topex Cherry, labeled by Dentsply Caulk. 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 Dentsply Caulk on February 19, 1963. The current certification is valid through December 31, 2017.

How is this Dentsply Caulk product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10216307101. 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)
10216-3071-1
11-Digit CMS (5-4-2)
10216-3071-01

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