Thallous Chloride Tl 201 Injection, Solution
NDC Package 69945-120-56

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

Package Information

Thallous Chloride Tl 201 injection is a diagnostic radiopharmaceutical indicated for Myocardial perfusion imaging with planar scintigraphy or single-photon emission computed tomography (SPECT)  for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction) which may have prognostic value regarding survival. This formulation utilizes a injection, solution delivery system. Marketed by Curium Us Llc, this product is identified by NDC 69945-120 and is authorized under FDA application NDA018150.

Identification & Billing

NDC Package Code
69945-120-56
Package Description
1 VIAL in 1 CAN / 5.6 mL in 1 VIAL
Product Code
69945-120
11-Digit Billing Format
69945012056

Clinical Specifications

Proprietary Name
Thallous Chloride Tl 201
Non-Proprietary Name
Thallous Chloride, Tl 201
Substance Name
Thallous Chloride Tl-201
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)
THALLOUS CHLORIDE TL-201 1 mCi/mL
Pharmacologic Class
Usage Information
Thallous Chloride Tl 201 Injection is a diagnostic radiopharmaceutical indicated for Myocardial perfusion imaging with planar scintigraphy or single-photon emission computed tomography (SPECT)  for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction) which may have prognostic value regarding survival. Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress.Localization of sites of parathyroid hyperactivity pre- and post-operatively in patients with elevated serum calcium and parathyroid hormone levels.

Regulatory & Marketing

Labeler Name
Curium Us Llc
Product Type
Human Prescription Drug
FDA Application #
NDA018150
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-04-2015
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 69945-120-56 identifies a specific commercial package of 1 vial in 1 can / 5.6 ml in 1 vial of Thallous Chloride Tl 201, a human prescription drug labeled by Curium Us Llc. This injection, solution is formulated for intravenous use and contains thallous chloride tl-201 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 November 04, 2015. 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: 69945012056. 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)
69945-120-56
11-Digit CMS (5-4-2)
69945-0120-56

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