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  5. NDC Package Code: 17156-067-30 Vizamyl

NDC Package 17156-067-30 Vizamyl

Flutemetamol F-18 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:
17156-067-30
Package Description:
1 VIAL, MULTI-DOSE in 1 CONTAINER / 30 mL in 1 VIAL, MULTI-DOSE
Product Code:
17156-067
Proprietary Name:
Vizamyl
Non-Proprietary Name:
Flutemetamol F-18
Substance Name:
Flutemetamol F-18
Usage Information:
Vizamyl is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline.A negative Vizamyl scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Vizamyl scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as in older people with normal cognition. Vizamyl is an adjunct to other diagnostic evaluations.Limitations of Use:A positive Vizamyl scan does not establish a diagnosis of AD or other cognitive disorder.Safety and effectiveness of Vizamyl have not been established for:Predicting development of dementia or other neurologic condition.Monitoring responses to therapies.
11-Digit NDC Billing Format:
17156006730
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
Product Type:
Human Prescription Drug
Labeler Name:
Medi-physics, Inc. Dba Ge Healthcare
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • FLUTEMETAMOL F-18 4.05 mCi/mL
    • Pharmacologic Class(es):
  • Radioactive Diagnostic Agent - [EPC] (Established Pharmacologic Class)
  • Radiopharmaceutical Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA203137
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-01-2014
    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 17156-067-30?

    The NDC Packaged Code 17156-067-30 is assigned to a package of 1 vial, multi-dose in 1 container / 30 ml in 1 vial, multi-dose of Vizamyl, a human prescription drug labeled by Medi-physics, Inc. Dba Ge Healthcare. The product's dosage form is solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 17156-067 included in the NDC Directory?

    Yes, Vizamyl with product code 17156-067 is active and included in the NDC Directory. The product was first marketed by Medi-physics, Inc. Dba Ge Healthcare on January 01, 2014 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 NDC billing unit for package 17156-067-30?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 17156-067-30?

    The 11-digit format is 17156006730. 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
    5-3-217156-067-305-4-217156-0067-30