Isodine Copitos
NDC Package 65734-511-72

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.

Isodine Copitos is hold the swab vertically, with the color ring tip upwards, Hold n the center of the tube with one hand at the color ring with the other.Gently snap the tip with the color ring, Formula inside the tube flows down and fills the opposite tip.Apply the product to the affected area.Discard swab after use. Marketed by Swabplus Inc., this product is identified by NDC 65734-511 and is authorized under FDA application part333C.

Identification & Billing

NDC Package Code
65734-511-72
Package Description
72 APPLICATOR in 1 PACKAGE / .15 mL in 1 APPLICATOR (65734-511-00)
Product Code
65734-511
11-Digit Billing Format
65734051172

Clinical Specifications

Proprietary Name
Isodine Copitos
Dosage Form
-
Usage Information
Hold the swab vertically, with the color ring tip upwards, Hold n the center of the tube with one hand at the color ring with the other.Gently snap the tip with the color ring, Formula inside the tube flows down and fills the opposite tip.Apply the product to the affected area.Discard swab after use.

Regulatory & Marketing

Labeler Name
Swabplus Inc.
FDA Application #
part333C
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
06-01-2008
Listing Expiration
12-31-2018
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 65734-511-72 identifies a specific commercial package of 72 applicator in 1 package / .15 ml in 1 applicator (65734-511-00) of Isodine Copitos, labeled by Swabplus 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 Swabplus Inc. on June 01, 2008. The current certification is valid through December 31, 2018.

How is this Swabplus Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65734051172. 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)
65734-511-72
11-Digit CMS (5-4-2)
65734-0511-72

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