Amyvid Injection, Solution
NDC Package 0002-1200-48

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

Amyvid (florbetapir f 18) injection is amyvid 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. This formulation utilizes a injection, solution delivery system. Marketed by Eli Lilly And Company, this product is identified by NDC 0002-1200 and is authorized under FDA application NDA202008.

Identification & Billing

NDC Package Code
0002-1200-48
Package Description
1 VIAL, MULTI-DOSE in 1 CAN / 100 mL in 1 VIAL, MULTI-DOSE
Product Code
0002-1200
11-Digit Billing Format
00002120048

Clinical Specifications

Proprietary Name
Amyvid
Non-Proprietary Name
Florbetapir F 18
Substance Name
Florbetapir F-18
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
FLORBETAPIR F-18 51 mCi/mL
Pharmacologic Class
Usage Information
Amyvid 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 Amyvid 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 Amyvid 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 older people with normal cognition. Amyvid is an adjunct to other diagnostic evaluations.

Regulatory & Marketing

Labeler Name
Eli Lilly And Company
Product Type
Human Prescription Drug
FDA Application #
NDA202008
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-01-2012
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 (0002-1200). Click a package code to view its specific billing and regulatory data.

0002-1200-50
1 VIAL, MULTI-DOSE in 1 CAN / 50 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 0002-1200-48 identifies a specific commercial package of 1 vial, multi-dose in 1 can / 100 ml in 1 vial, multi-dose of Amyvid, a human prescription drug labeled by Eli Lilly And Company. This injection, solution is formulated for intravenous use and contains florbetapir 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 Eli Lilly And Company on June 01, 2012. The current certification is valid through December 31, 2027.

How is this Eli Lilly And Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00002120048. 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 (4-4-2)
0002-1200-48
11-Digit CMS (5-4-2)
00002-1200-48

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