Neuraceq Injection, Solution
NDC Package 54828-001-30

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

Neuraceq (florbetaben f 18) injection is neuraceq 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 Neuraceq scan indicates sparse to no amyloid 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 injection, solution delivery system. Marketed by Lantheus Biosciences Ltd., A Lantheus Company, this product is identified by NDC 54828-001 and is authorized under FDA application NDA204677.

Identification & Billing

NDC Package Code
54828-001-30
Package Description
1 VIAL, MULTI-DOSE in 1 CONTAINER / 30 mL in 1 VIAL, MULTI-DOSE
Product Code
54828-001
11-Digit Billing Format
54828000130
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
Neuraceq
Non-Proprietary Name
Florbetaben F 18
Substance Name
Florbetaben 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)
FLORBETABEN F-18 135 mCi/mL
Pharmacologic Class
Usage Information
Neuraceq 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 Neuraceq scan indicates sparse to no amyloid 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 Neuraceq 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. Neuraceq is an adjunct to other diagnostic evaluations.Limitations of Use    • A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder.    • Safety and effectiveness of Neuraceq have not been established for:       • Predicting development of dementia or other neurologic conditions;       • Monitoring responses to therapies.

Regulatory & Marketing

Labeler Name
Lantheus Biosciences Ltd., A Lantheus Company
Product Type
Human Prescription Drug
FDA Application #
NDA204677
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-20-2014
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 (54828-001). Click a package code to view its specific billing and regulatory data.

54828-001-50
1 VIAL, MULTI-DOSE in 1 CONTAINER / 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 54828-001-30 identifies a specific commercial package of 1 vial, multi-dose in 1 container / 30 ml in 1 vial, multi-dose of Neuraceq, a human prescription drug labeled by Lantheus Biosciences Ltd., A Lantheus Company. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, solution is formulated for intravenous use and contains florbetaben 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 Lantheus Biosciences Ltd., A Lantheus Company on March 20, 2014. The current certification is valid through December 31, 2027.

How is this Lantheus Biosciences Ltd., A Lantheus Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54828000130. 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)
54828-001-30
11-Digit CMS (5-4-2)
54828-0001-30

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