Professional Whitening System Whitening
NDC Package 62111-0213-2

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.

Professional Whitening System Whitening is supervise children as necessary until capable of using without supervision.■ Adults and children 6 years of age and older, brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by adentist or physician.■ Children under 12 years, instruct in good brushing and rinsing habits (to minimize swallowing).■ Children under 6 years, do not use unless directed by a dentist or physician. Marketed by Akg Innovations Llc, this product is identified by NDC 62111-0213 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
62111-0213-2
Package Description
1 TUBE in 1 PACKAGE / 113.6 g in 1 TUBE
Product Code
62111-0213
11-Digit Billing Format
62111021302
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Professional Whitening System Whitening
Dosage Form
-
Usage Information
Supervise children as necessary until capable of using without supervision.■ Adults and children 6 years of age and older, brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by adentist or physician.■ Children under 12 years, instruct in good brushing and rinsing habits (to minimize swallowing).■ Children under 6 years, do not use unless directed by a dentist or physician.

Regulatory & Marketing

Labeler Name
Akg Innovations Llc
FDA Application #
part355
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
02-14-2014
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 62111-0213-2 identifies a specific commercial package of 1 tube in 1 package / 113.6 g in 1 tube of Professional Whitening System Whitening, labeled by Akg Innovations Llc. 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 Akg Innovations Llc on February 14, 2014. The current certification is valid through December 31, 2017.

How is this Akg Innovations Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62111021302. 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)
62111-0213-2
11-Digit CMS (5-4-2)
62111-0213-02

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