Cainetips
NDC Package 70769-101-51

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.

Cainetips is hOLD WITH SOLID WHITE TIP STRAIGHT DOWN; BEND AND SNAP OPEN UPPER TIP AT COLORED RING; ALLOW MEDICINE TO FLOW DOWN.APPLY PRODUCT TO INTENDED AREA; ALLOW IT TO REMAIN IN PLACE AT LEAST 1 MINUTE AND THEN REMOVE IT FROM MOUTH; DISPOSE AFTER APPLICATION.USE UP TO 4 TIMES DAILY, OR AS DIRECTED BY A DENTIST. Marketed by J Morita Usa Inc, this product is identified by NDC 70769-101 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
70769-101-51
Package Description
100 APPLICATOR in 1 BOX / .15 mL in 1 APPLICATOR (70769-101-11)
Product Code
70769-101
11-Digit Billing Format
70769010151

Clinical Specifications

Proprietary Name
Cainetips
Dosage Form
-
Usage Information
HOLD WITH SOLID WHITE TIP STRAIGHT DOWN; BEND AND SNAP OPEN UPPER TIP AT COLORED RING; ALLOW MEDICINE TO FLOW DOWN.APPLY PRODUCT TO INTENDED AREA; ALLOW IT TO REMAIN IN PLACE AT LEAST 1 MINUTE AND THEN REMOVE IT FROM MOUTH; DISPOSE AFTER APPLICATION.USE UP TO 4 TIMES DAILY, OR AS DIRECTED BY A DENTIST. ADULT SUPERVISION REQUIRED FOR USE WITH CHILDREN UNDER 12 YEARS. CONSULT A DENTAL PROFESSIONAL FOR USE WITH CHILDREN UNDER 2 YEARS.

Regulatory & Marketing

Labeler Name
J Morita Usa Inc
FDA Application #
part348
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
06-06-2016
Listing Expiration
12-31-2024
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 70769-101-51 identifies a specific commercial package of 100 applicator in 1 box / .15 ml in 1 applicator (70769-101-11) of Cainetips, labeled by J Morita Usa 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 J Morita Usa Inc on June 06, 2016. The current certification is valid through December 31, 2024.

How is this J Morita Usa Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70769010151. 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)
70769-101-51
11-Digit CMS (5-4-2)
70769-0101-51

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