Pro Care Flouride
NDC Package 78989-001-01

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.

Pro Care Flouride is adults and children 2 years of age and older. Marketed by Diligo Holdings Joint Stock Company, this product is identified by NDC 78989-001 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
78989-001-01
Package Description
1 TUBE in 1 BOX / 185 g in 1 TUBE
Product Code
78989-001
11-Digit Billing Format
78989000101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pro Care Flouride
Dosage Form
-
Usage Information
Adults and children 2 years of age and older. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentis or doctor. Children under 6 years old of age. Intruct in good brushing and rinsing habits ( to minimize swallowing) Supevise children as necessary until capable of using without supervison. Children under 2 years old of age. Consult a dentist or doctor.

Regulatory & Marketing

Labeler Name
Diligo Holdings Joint Stock Company
FDA Application #
part355
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
08-05-2020
Listing Expiration
12-31-2021
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 78989-001-01 identifies a specific commercial package of 1 tube in 1 box / 185 g in 1 tube of Pro Care Flouride, labeled by Diligo Holdings Joint Stock Company. 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 Diligo Holdings Joint Stock Company on August 05, 2020. The current certification is valid through December 31, 2021.

How is this Diligo Holdings Joint Stock Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78989000101. 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)
78989-001-01
11-Digit CMS (5-4-2)
78989-0001-01

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