Gallium Citrate Ga-67 Injection, Solution
NDC Package 69945-180-06

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

Package Information

Gallium Citrate Ga-67 injection may be useful to demonstrate the presence and extent of Hodgkin's disease, lymphoma, and bronchogenic carcinoma. This formulation utilizes a injection, solution delivery system. Marketed by Curium Us Llc, this product is identified by NDC 69945-180 and is authorized under FDA application NDA018058.

Identification & Billing

NDC Package Code
69945-180-06
Package Description
1 VIAL in 1 CAN / 3.3 mL in 1 VIAL
Product Code
69945-180
11-Digit Billing Format
69945018006

Clinical Specifications

Proprietary Name
Gallium Citrate Ga-67
Non-Proprietary Name
Gallium Citrate Ga-67
Substance Name
Gallium Chloride Ga-67
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)
GALLIUM CHLORIDE GA-67 2 mCi/mL
Usage Information
Gallium Citrate Ga 67 Injection may be useful to demonstrate the presence and extent of Hodgkin's disease, lymphoma, and bronchogenic carcinoma. Positive gallium Ga-67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state. Gallium Citrate Ga 67 Injection may be useful as an aid in detecting some acute inflammatory lesions.

Regulatory & Marketing

Labeler Name
Curium Us Llc
Product Type
Human Prescription Drug
FDA Application #
NDA018058
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-21-2008
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69945-180). Click a package code to view its specific billing and regulatory data.

69945-180-12
1 VIAL in 1 CAN / 6.6 mL in 1 VIAL

* 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 69945-180-06 identifies a specific commercial package of 1 vial in 1 can / 3.3 ml in 1 vial of Gallium Citrate Ga-67, a human prescription drug labeled by Curium Us Llc. This injection, solution is formulated for intravenous use and contains gallium chloride ga-67 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 February 21, 2008. 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: 69945018006. 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)
69945-180-06
11-Digit CMS (5-4-2)
69945-0180-06

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