I2pure I2rx Gel
NDC Package 83465-421-30

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

Package Information

I2pure I2rx (antiseptic and skin protectant gel) gel is classified as a

administered via topical route. This formulation utilizes a gel delivery system. Marketed by I2pure Corp, this product is identified by NDC 83465-421 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
83465-421-30
Package Description
30 mL in 1 TUBE
Product Code
83465-421
11-Digit Billing Format
83465042130

Clinical Specifications

Proprietary Name
I2pure I2rx
Non-Proprietary Name
Antiseptic And Skin Protectant Gel
Substance Name
Glycerin; Iodine
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
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)
Pharmacologic Class

Regulatory & Marketing

Labeler Name
I2pure Corp
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-11-2026
Listing Expiration
12-31-2027
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 83465-421-30 identifies a specific commercial package of 30 ml in 1 tube of I2pure I2rx, a human over the counter drug labeled by I2pure Corp. This gel is formulated for topical use and contains glycerin; iodine 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 I2pure Corp on May 11, 2026. The current certification is valid through December 31, 2027.

How is this I2pure Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83465042130. 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)
83465-421-30
11-Digit CMS (5-4-2)
83465-0421-30

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