Ionite R Liquid
NDC Package 53045-265-64

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ionite R (sodium fluoride) liquids is this is a one-minute, ready-to-use fluoride treatment rinse for in-office patient use. This formulation utilizes a liquid delivery system. Marketed by Dharma Research, Inc., this product is identified by NDC 53045-265.

Identification & Billing

NDC Package Code
53045-265-64
Package Description
1.9 L in 1 BOTTLE, PUMP
Product Code
53045-265
11-Digit Billing Format
53045026564
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ionite R
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
  • Dental - Administration to a tooth or teeth.
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM FLUORIDE 38 g/L
Usage Information
This is a one-minute, ready-to-use fluoride treatment rinse for in-office patient use. Remove cap from bottle and insert enclosed pump into bottle and tighten. Pump ½ oz into a cup. Instruct patient to thoroughly rinse the entire amount around and between teeth for one minute, then spit-out rinse. Repeat the procedure to ensure maximum benefit. Instruct patient not to eat or drink for at least 30 minutes.

Regulatory & Marketing

Labeler Name
Dharma Research, Inc.
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
11-03-2013
Listing Expiration
12-31-2026
Exclude Flag
N
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 53045-265-64 identifies a specific commercial package of 1.9 l in 1 bottle, pump of Ionite R, a human prescription drug labeled by Dharma Research, Inc.. This liquid is formulated for dental; oral use and contains sodium fluoride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Dharma Research, Inc. on November 03, 2013. The current certification is valid through December 31, 2026.

How is this Dharma Research, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53045026564. 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)
53045-265-64
11-Digit CMS (5-4-2)
53045-0265-64

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