Iodine I-131 Solution
NDC Package 64805-1315-1

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Iodine I-131 solution is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a solution delivery system. Marketed by Institut National Des Radioelements, this product is identified by NDC 64805-1315.

Identification & Billing

NDC Package Code
64805-1315-1
Package Description
20 mL in 1 BOTTLE
Product Code
64805-1315
11-Digit Billing Format
64805131501

Clinical Specifications

Proprietary Name
Iodine I-131
Non-Proprietary Name
Iodine I-131
Substance Name
Iodine I-131
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Active Ingredient(s)
IODINE I-131 350 U/mL

Regulatory & Marketing

Labeler Name
Institut National Des Radioelements
Product Type
Bulk Ingredient
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
11-13-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 64805-1315-1 identifies a specific commercial package of 20 ml in 1 bottle of Iodine I-131 (UNFINISHED drug), a bulk ingredient labeled by Institut National Des Radioelements. This solution is formulated for use and contains iodine i-131 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 Institut National Des Radioelements on November 13, 2017. The current certification is valid through December 31, 2026.

How is this Institut National Des Radioelements product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64805131501. 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)
64805-1315-1
11-Digit CMS (5-4-2)
64805-1315-01

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