Colloidal Iodine
NDC Package 69164-2001-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Colloidal Iodine is it is better to dose on an empty stomachthe dosage on undiluted solution is possibly recommendeddo eat nothing within five minutes after the dosageunit dose is 30mldo take unit dose three times a day before each meal (morning, daylight, evening)keep this dose guide for a monthif effective, do change the unit dose twice a day before each meal (morning, evening)do discuss with your doctor for further dose. Marketed by Jci Institute Of Medical Science, this product is identified by NDC 69164-2001 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
69164-2001-1
Package Description
500 mL in 1 BOTTLE, GLASS
Product Code
11-Digit Billing Format
69164200101

Clinical Specifications

Proprietary Name
Colloidal Iodine
Dosage Form
-
Usage Information
It is better to dose on an empty stomachthe dosage on undiluted solution is possibly recommendeddo eat nothing within five minutes after the dosageunit dose is 30mldo take unit dose three times a day before each meal (morning, daylight, evening)keep this dose guide for a monthif effective, do change the unit dose twice a day before each meal (morning, evening)do discuss with your doctor for further dose

Regulatory & Marketing

Labeler Name
Jci Institute Of Medical Science
FDA Application #
part333A
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
08-27-2014
Listing Expiration
12-31-2019
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 69164-2001-1 identifies a specific commercial package of 500 ml in 1 bottle, glass of Colloidal Iodine, labeled by Jci Institute Of Medical Science. 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 Jci Institute Of Medical Science on August 27, 2014. The current certification is valid through December 31, 2019.

How is this Jci Institute Of Medical Science product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69164200101. 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 (5-4-1)
69164-2001-1
11-Digit CMS (5-4-2)
69164-2001-01

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