Prescription medicine
Florbetaben f 18 Brand names: Neuraceq
Florbetaben f 18 (Neuraceq) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the florbetaben f 18 FDA label on DailyMed (effective July 24, 2026, Lantheus Biosciences Ltd., a Lantheus company); the NDA 204677 record on Drugs@FDA; every florbetaben f 18 label on DailyMed.
Highlights of the record
FDA label of July 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageNEURACEQ is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products NEURACEQ is a radioactive diagnos
Forms and strengths
Injection (solution).
On the market
- Earliest approval on file
- March 19, 2014 Neuraceq, Lantheus; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 14, 2032 Neuraceq injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2023 0 Class I among all firms' recalls; latest August 22, 2023
- FAERS reports
- 21 through July 30, 2026
What is florbetaben f 18 used for?
From the label: indications and usageNEURACEQ is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products NEURACEQ is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products […]
FDA pharmacologic class: Radioactive Diagnostic Agent.
Source: FDA drug label (Neuraceq), Lantheus Biosciences Ltd., a Lantheus company, effective July 24, 2026 (SPL set b0915068-cfd4-4d72-b9f8-7e31fe83cd1e), via openFDA; the full label on DailyMed
Is there a generic for florbetaben f 18 (Neuraceq)?
No generic florbetaben f 18 is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Neuraceq injection: the compound patent runs to March 18, 2029, and the last listed entry to July 14, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2032 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has florbetaben f 18 been recalled?
The FDA's Enforcement Report lists 1 recall naming florbetaben f 18 since 2023: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 22, 2023 | Class II | Sofie Co dba Sofie | Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT). |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for florbetaben f 18?
The FDA Adverse Event Reporting System holds 21 reports that list florbetaben f 18 among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 2 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other radioactive diagnostic agents
- the pharmacologic class, with prices and generics
- Florbetaben f 18 side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other