Dentek Canker Cover
NDC Package 60630-091-04

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.

Dentek Canker Cover is uses: for the relief of pain associated with:. Marketed by Dentek Oral Care, Inc., this product is identified by NDC 60630-091 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
60630-091-04
Package Description
1 DOSE PACK in 1 PACKET / 2.5 mg in 1 DOSE PACK (60630-091-01)
Product Code
60630-091
11-Digit Billing Format
60630009104
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dentek Canker Cover
Dosage Form
-
Usage Information
Uses: for the relief of pain associated with: . canker sores . mouth sores

Regulatory & Marketing

Labeler Name
Dentek Oral Care, Inc.
FDA Application #
part356
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
11-11-2015
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 (60630-091). Click a package code to view its specific billing and regulatory data.

60630-091-02
6 DOSE PACK in 1 CARTON / 2.5 mg in 1 DOSE PACK (60630-091-01)
60630-091-03
8 DOSE PACK in 1 CARTON / 2.5 mg in 1 DOSE 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 60630-091-04 identifies a specific commercial package of 1 dose pack in 1 packet / 2.5 mg in 1 dose pack (60630-091-01) of Dentek Canker Cover, labeled by Dentek Oral Care, 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 Dentek Oral Care, Inc. on November 11, 2015. The current certification is valid through December 31, 2017.

How is this Dentek Oral Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60630009104. 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)
60630-091-04
11-Digit CMS (5-4-2)
60630-0091-04

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