Locametz Injection, Powder, Lyophilized, For Solution
NDC Package 69488-017-61

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

Package Information

Locametz (kit for the preparation of gallium ga 68 gozetotide) injection is lOCAMETZ, after radiolabeling with gallium-68, 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.for selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Advanced Accelerator Applications Usa, Inc, this product is identified by NDC 69488-017 and is authorized under FDA application NDA215841.

Identification & Billing

NDC Package Code
69488-017-61
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE
Product Code
69488-017
11-Digit Billing Format
69488001761
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Locametz
Non-Proprietary Name
Kit For The Preparation Of Gallium Ga 68 Gozetotide
Substance Name
Gozetotide
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
GOZETOTIDE 25 ug/1
Usage Information
LOCAMETZ, after radiolabeling with gallium-68, 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.for selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.

Regulatory & Marketing

Labeler Name
Advanced Accelerator Applications Usa, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA215841
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-23-2022
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

A9800
Source: OPPS
Gallium locametz 1 millicuri
HCPCS Dosage 1 mCi
Units / Pkg 1

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 69488-017-61 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, multi-dose of Locametz, a human prescription drug labeled by Advanced Accelerator Applications Usa, Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains 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 Advanced Accelerator Applications Usa, Inc on March 23, 2022. The current certification is valid through December 31, 2026.

How is this Advanced Accelerator Applications Usa, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69488001761. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
69488-017-61
11-Digit CMS (5-4-2)
69488-0017-61

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