Ionite Apf Aerosol, Foam
NDC Package 53045-252-44

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

Package Information

Ionite Apf (sodium fluoride) aerosols is a human prescription drug administered via dental; oral; topical route. This formulation utilizes a aerosol, foam delivery system. Marketed by Dharma Research, Inc., this product is identified by NDC 53045-252.

Identification & Billing

NDC Package Code
53045-252-44
Package Description
126 g in 1 BOTTLE
Product Code
53045-252
11-Digit Billing Format
53045025244
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ionite Apf Foam
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.
Administration Route
  • Dental - Administration to a tooth or teeth.
  • Oral - Administration to or by way of the mouth.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
SODIUM FLUORIDE 1.5498 g/126g

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
04-22-2013
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 53045-252-44 identifies a specific commercial package of 126 g in 1 bottle of Ionite Apf Foam, a human prescription drug labeled by Dharma Research, Inc.. This aerosol, foam is formulated for dental; oral; topical 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 April 22, 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: 53045025244. 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)
53045-252-44
11-Digit CMS (5-4-2)
53045-0252-44

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