Sodium Iodide I-131 Kit
NDC Package 69208-000-00

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

Package Information

Sodium Iodide I-131 kits is sodium Iodide I-131 is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma. This formulation utilizes a kit delivery system. Marketed by Radnostix, Inc., this product is identified by NDC 69208-000 and is authorized under FDA application ANDA209166.

Identification & Billing

NDC Package Code
69208-000-00
Package Description
1 KIT in 1 BOX * 3 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-35) * 2 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-25) * 1 CARTON in 1 BOX / 2 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK * 1 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-15)
Product Code
69208-000
11-Digit Billing Format
69208000000

Clinical Specifications

Proprietary Name
Sodium Iodide I-131
Non-Proprietary Name
Sodium Iodide I-131
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
Sodium Iodide I-131 is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma.

Regulatory & Marketing

Labeler Name
Radnostix, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA209166
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-16-2020
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage
  • 69208 - Radnostix, Inc.
    • 69208-000 - Sodium Iodide I-131
      • 69208-000-00 - 1 KIT in 1 BOX * 3 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-35) * 2 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-25) * 1 CARTON in 1 BOX / 2 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK * 1 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-15)

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 69208-000-00 identifies a specific commercial package of 1 kit in 1 box * 3 solution, concentrate in 1 vial, dispensing (69208-003-35) * 2 solution, concentrate in 1 vial, dispensing (69208-003-25) * 1 carton in 1 box / 2 blister pack in 1 carton / 10 capsule in 1 blister pack * 1 solution, concentrate in 1 vial, dispensing (69208-003-15) of Sodium Iodide I-131, a human prescription drug labeled by Radnostix, Inc.. This kit is formulated for oral use and contains 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 Radnostix, Inc. on March 16, 2020. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69208000000. 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)
69208-000-00
11-Digit CMS (5-4-2)
69208-0000-00

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