Ioflupane I 123 Injection, Solution
NDC Package 69945-166-05

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

Package Information

Ioflupane I 123 injection is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). This formulation utilizes a injection, solution delivery system. Marketed by Curium Us Llc, this product is identified by NDC 69945-166 and is authorized under FDA application ANDA213792.

Identification & Billing

NDC Package Code
69945-166-05
Package Description
2.5 mL in 1 VIAL, SINGLE-DOSE
Product Code
69945-166
11-Digit Billing Format
69945016605

Clinical Specifications

Proprietary Name
Ioflupane I 123
Non-Proprietary Name
Ioflupane I-123
Substance Name
Ioflupane I-123
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
IOFLUPANE I-123 2 mCi/mL
Pharmacologic Class
Usage Information
Ioflupane I 123 Injection is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). In these patients, Ioflupane I 123 Injection may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson's disease, multiple system atrophy and progressive supranuclear palsy). Ioflupane I 123 Injection is an adjunct to other diagnostic evaluations.

Regulatory & Marketing

Labeler Name
Curium Us Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA213792
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-31-2022
Listing Expiration
12-31-2026
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 69945-166-05 identifies a specific commercial package of 2.5 ml in 1 vial, single-dose of Ioflupane I 123, a human prescription drug labeled by Curium Us Llc. This injection, solution is formulated for intravenous use and contains ioflupane i-123 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 Curium Us Llc on March 31, 2022. The current certification is valid through December 31, 2026.

How is this Curium Us Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69945016605. 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)
69945-166-05
11-Digit CMS (5-4-2)
69945-0166-05

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