Finefra Clinic Tooth
NDC Package 69653-030-02

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.

Finefra Clinic Tooth is directions:Adults and children 2 yrs. Marketed by Jewoo Medical Co,.ltd, this product is identified by NDC 69653-030 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
69653-030-02
Package Description
1 TUBE in 1 CARTON / 100 g in 1 TUBE (69653-030-01)
Product Code
69653-030
11-Digit Billing Format
69653003002
RxNorm Crosswalk
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.0076 MG/MG Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste

Clinical Specifications

Proprietary Name
Finefra Clinic Tooth 100g
Dosage Form
-
Usage Information
Directions:Adults and children 2 yrs. older: Brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician. Do not swallow. Children under 6 yrs.: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. Children under 2 yrs.: Ask a dentist or physician.

Regulatory & Marketing

Labeler Name
Jewoo Medical Co,.ltd
FDA Application #
part355
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
05-01-2018
Listing Expiration
12-31-2022
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 69653-030-02 identifies a specific commercial package of 1 tube in 1 carton / 100 g in 1 tube (69653-030-01) of Finefra Clinic Tooth 100g, labeled by Jewoo Medical Co,.ltd. 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 Jewoo Medical Co,.ltd on May 01, 2018. The current certification is valid through December 31, 2022.

How is this Jewoo Medical Co,.ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69653003002. 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)
69653-030-02
11-Digit CMS (5-4-2)
69653-0030-02

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