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Neuraceq

Florbetaben F 18 · FLORBETABEN F-18 135 mCi/mL · Injection, Solution · Intravenous · Lantheus Biosciences Ltd., a Lantheus company

NDC 54828-0001-50 · 1 VIAL, MULTI-DOSE in 1 CONTAINER / 50 mL in 1 VIAL, MULTI-DOSE · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Medicaid spend (2025)

$12,072
22 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA204677
TE code
Approval date
Mar 19, 2014
Patents / exclusivity
2 patents, 0 exclusivities
TypeNumber / codeExpires
patent9308284Jul 14, 2032
patent7807135Mar 18, 2029

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedAug 22, 2023
    Sofie Co dba SofieLack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).

Manufacturers of Florbetaben F 18 (Injection, Solution)

LabelerStrengthFirst seenLast seen
Lantheus Biosciences Ltd., a Lantheus companyFLORBETABEN F-18 135 mCi/mLJul 29, 2026Sep 2, 2026
Lantheus Biosciences Ltd., a Lantheus CompanyFLORBETABEN F-18 135 mCi/mLJul 15, 2026Jul 22, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Neuraceq — NDC 54828-0001-50," retrieved September 3, 2026, https://drugdashboards.com/drug/54828000150.

Free to cite with attribution — see how the data is put together.