NDC Package 69803-100-10 Kovanaze

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
69803-100-10
Package Description:
30 APPLICATOR in 1 CARTON / .2 mL in 1 APPLICATOR
Product Code:
Proprietary Name:
Kovanaze
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.
11-Digit NDC Billing Format:
69803010010
NDC to RxNorm Crosswalk:
  • RxCUI: 1809050 - oxymetazoline HCl 0.1 MG / tetracaine HCl 6 MG per 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
  • Labeler Name:
    St. Renatus
    Sample Package:
    No
    Start Marketing Date:
    09-01-2016
    Listing Expiration Date:
    12-31-2020
    Exclude Flag:
    I
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 69803-100-10?

    The NDC Packaged Code 69803-100-10 is assigned to a package of 30 applicator in 1 carton / .2 ml in 1 applicator of Kovanaze, labeled by St. Renatus. The product's dosage form is and is administered via form.

    Is NDC 69803-100 included in the NDC Directory?

    No, Kovanaze with product code 69803-100 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by St. Renatus on September 01, 2016 and its listing in the NDC Directory is set to expire on December 31, 2020 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 69803-100-10?

    The 11-digit format is 69803010010. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-269803-100-105-4-269803-0100-10