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  5. NDC Package Code: 76376-618-30 Fludeoxyglucose F 18

NDC Package 76376-618-30 Fludeoxyglucose F 18

Fludeoxyglucose F-18 Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
76376-618-30
Package Description:
30 mL in 1 VIAL, MULTI-DOSE
Product Code:
76376-618
Proprietary Name:
Fludeoxyglucose F 18
Non-Proprietary Name:
Fludeoxyglucose F-18
Substance Name:
Fludeoxyglucose F-18
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.
11-Digit NDC Billing Format:
76376061830
Product Type:
Human Prescription Drug
Labeler Name:
Hamamatsu/queen�s Pet Imaging Center, Llc
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(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • FLUDEOXYGLUCOSE F-18 100 mCi/mL
    • Pharmacologic Class(es):
  • Radioactive Diagnostic Agent - [EPC] (Established Pharmacologic Class)
  • Radiopharmaceutical Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA203771
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-14-2011
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 76376-618-30?

    The NDC Packaged Code 76376-618-30 is assigned to a package of 30 ml in 1 vial, multi-dose of Fludeoxyglucose F 18, a human prescription drug labeled by Hamamatsu/queen�s Pet Imaging Center, Llc. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 76376-618 included in the NDC Directory?

    Yes, Fludeoxyglucose F 18 with product code 76376-618 is active and included in the NDC Directory. The product was first marketed by Hamamatsu/queen�s Pet Imaging Center, Llc on November 14, 2011 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 76376-618-30?

    The 11-digit format is 76376061830. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-276376-618-305-4-276376-0618-30