Kovanaze
NDC Package 69803-100-10

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.

Kovanaze is tM is indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J in adults and children who weigh 40 kg or more. Marketed by St. Renatus, this product is identified by NDC 69803-100 and is authorized under FDA application NDA208032.

Identification & Billing

NDC Package Code
69803-100-10
Package Description
30 APPLICATOR in 1 CARTON / .2 mL in 1 APPLICATOR
Product Code
69803-100
11-Digit Billing Format
69803010010
RxNorm Crosswalk
  • RxCUI: 1809050 - oxymetazoline HCl 0.1 MG / tetracaine HCl 6 MG in 0.2 ML Metered Dose Nasal Spray
  • RxCUI: 1809050 - oxymetazoline hydrochloride 0.1 MG/ACTUAT / tetracaine hydrochloride 6 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1809050 - oxymetazoline hydrochloride 0.1 MG / tetracaine hydrochloride 6 MG per 0.2 ML Metered Dose Nasal Spray
  • RxCUI: 1809050 - oxymetazoline hydrochloride 0.5 MG/ML / tetracaine hydrochloride 30 MG/ML Metered Dose Nasal Spray
  • RxCUI: 1809056 - KOVANAZE 0.1 MG / 6 MG in 0.2 ML Metered Dose Nasal Spray

Clinical Specifications

Proprietary Name
Kovanaze
Dosage Form
-
Usage Information
KOVANAZE TM is indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J in adults and children who weigh 40 kg or more.

Regulatory & Marketing

Labeler Name
St. Renatus
FDA Application #
NDA208032
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-01-2016
Listing Expiration
12-31-2020
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 69803-100-10 identifies a specific commercial package of 30 applicator in 1 carton / .2 ml in 1 applicator of Kovanaze, labeled by St. Renatus. 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 St. Renatus on September 01, 2016. The current certification is valid through December 31, 2020.

How is this St. Renatus product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69803010010. 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)
69803-100-10
11-Digit CMS (5-4-2)
69803-0100-10

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