Gallium Ga-68 Psma-11 Injection, Solution
NDC Package 71162-201-10

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

Package Information

Gallium Ga-68 Psma-11 (gallium ga-68 gozetotide) injection is gallium Ga 68 gozeotide injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:with suspected metastasis who are candidates for initial definitive therapy.with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. This formulation utilizes a injection, solution delivery system. Marketed by Ionetix Corporation, this product is identified by NDC 71162-201 and is authorized under FDA application ANDA219189.

Identification & Billing

NDC Package Code
71162-201-10
Package Description
9 mL in 1 SYRINGE
Product Code
71162-201
11-Digit Billing Format
71162020110

Clinical Specifications

Proprietary Name
Gallium Ga-68 Psma-11
Non-Proprietary Name
Gallium Ga-68 Gozetotide
Substance Name
Gallium Ga-68 Gozetotide
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 GA-68 GOZETOTIDE 5 mCi/mL
Pharmacologic Class
Usage Information
Gallium Ga 68 gozeotide injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:with suspected metastasis who are candidates for initial definitive therapy.with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Regulatory & Marketing

Labeler Name
Ionetix Corporation
Product Type
Human Prescription Drug
FDA Application #
ANDA219189
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-17-2024
Listing Expiration
12-31-2027
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71162-201-10 identifies a specific commercial package of 9 ml in 1 syringe of Gallium Ga-68 Psma-11, a human prescription drug labeled by Ionetix Corporation. This injection, solution is formulated for intravenous use and contains gallium ga-68 gozetotide 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 Ionetix Corporation on January 17, 2024. The current certification is valid through December 31, 2027.

How is this Ionetix Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71162020110. 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)
71162-201-10
11-Digit CMS (5-4-2)
71162-0201-10

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