NDC Package 54828-001-50 Neuraceq

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

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:
54828-001-50
Package Description:
1 VIAL, MULTI-DOSE in 1 CONTAINER / 50 mL in 1 VIAL, MULTI-DOSE
Product Code:
Proprietary Name:
Neuraceq
Non-Proprietary Name:
Florbetaben F 18
Substance Name:
Florbetaben F-18
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.
11-Digit NDC Billing Format:
54828000150
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:
Life Molecular Imaging, Ltd
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):
    Sample Package:
    No
    FDA Application Number:
    NDA204677
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-20-2014
    Listing Expiration Date:
    12-31-2025
    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 54828-001-50?

    The NDC Packaged Code 54828-001-50 is assigned to a package of 1 vial, multi-dose in 1 container / 50 ml in 1 vial, multi-dose of Neuraceq, a human prescription drug labeled by Life Molecular Imaging, Ltd. The product's dosage form is injection, 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 54828-001 included in the NDC Directory?

    Yes, Neuraceq with product code 54828-001 is active and included in the NDC Directory. The product was first marketed by Life Molecular Imaging, Ltd on March 20, 2014 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 54828-001-50?

    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 54828-001-50?

    The 11-digit format is 54828000150. 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
    5-3-254828-001-505-4-254828-0001-50