Fludeoxyglucose F 18
NDC Package 76376-618-30

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Fludeoxyglucose F 18 is injection, USP is indicated in positron emission tomography (PET) imaging for assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnoses of cancer.Fludeoxyglucose F 18 Injection, USP is indicated in positron emission tomography (PET) imaging in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging, for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function.Fludeoxyglucose F 18 Injection, USP is indicated in positron emission tomography (PET) imaging in patients for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. Marketed by Hamamatsu/queen�s Pet Imaging Center, Llc, this product is identified by NDC 76376-618 and is authorized under FDA application ANDA203771.

Identification & Billing

NDC Package Code
76376-618-30
Package Description
30 mL in 1 VIAL, MULTI-DOSE
Product Code
76376-618
11-Digit Billing Format
76376061830

Clinical Specifications

Proprietary Name
Fludeoxyglucose F 18
Dosage Form
-
Usage Information
Fludeoxyglucose F 18 Injection, USP is indicated in positron emission tomography (PET) imaging for assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnoses of cancer.Fludeoxyglucose F 18 Injection, USP is indicated in positron emission tomography (PET) imaging in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging, for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function.Fludeoxyglucose F 18 Injection, USP is indicated in positron emission tomography (PET) imaging in patients for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.

Regulatory & Marketing

Labeler Name
Hamamatsu/queen�s Pet Imaging Center, Llc
FDA Application #
ANDA203771
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-14-2011
Listing Expiration
12-31-2025
Exclude Flag
I
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 76376-618-30 identifies a specific commercial package of 30 ml in 1 vial, multi-dose of Fludeoxyglucose F 18, labeled by Hamamatsu/queen�s Pet Imaging Center, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Hamamatsu/queen�s Pet Imaging Center, Llc on November 14, 2011. The current certification is valid through December 31, 2025.

How is this Hamamatsu/queen�s Pet Imaging Center, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76376061830. 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)
76376-618-30
11-Digit CMS (5-4-2)
76376-0618-30

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