Vizamyl Solution
NDC Package 17156-067-10

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

Package Information

Vizamyl (flutemetamol f-18) solution is 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. This formulation utilizes a solution delivery system. Marketed by Ge Healthcare Inc. (medi-physics, Inc. Dba Ge Healthcare), this product is identified by NDC 17156-067 and is authorized under FDA application NDA203137.

Identification & Billing

NDC Package Code
17156-067-10
Package Description
1 VIAL, MULTI-DOSE in 1 CONTAINER / 10 mL in 1 VIAL, MULTI-DOSE
Product Code
17156-067
11-Digit Billing Format
17156006710
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
Vizamyl
Non-Proprietary Name
Flutemetamol F-18
Substance Name
Flutemetamol F-18
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
FLUTEMETAMOL F-18 4.05 mCi/mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Ge Healthcare Inc. (medi-physics, Inc. Dba Ge Healthcare)
Product Type
Human Prescription Drug
FDA Application #
NDA203137
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-01-2014
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.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (17156-067). Click a package code to view its specific billing and regulatory data.

17156-067-30
1 VIAL, MULTI-DOSE in 1 CONTAINER / 30 mL in 1 VIAL, MULTI-DOSE

* 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 17156-067-10 identifies a specific commercial package of 1 vial, multi-dose in 1 container / 10 ml in 1 vial, multi-dose of Vizamyl, a human prescription drug labeled by Ge Healthcare Inc. (medi-physics, Inc. Dba Ge Healthcare). This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This solution is formulated for intravenous use and contains flutemetamol f-18 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 Ge Healthcare Inc. (medi-physics, Inc. Dba Ge Healthcare) on January 01, 2014. The current certification is valid through December 31, 2027.

How is this Ge Healthcare Inc. (medi-physics, Inc. Dba Ge Healthcare) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17156006710. 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)
17156-067-10
11-Digit CMS (5-4-2)
17156-0067-10

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