What is NDC 54828-001?

54828-001 is the product NDC for Neuraceq (florbetaben f 18), Florbetaben f-18 135 mCi/mL injection, solution, listed with the FDA by Lantheus Biosciences Ltd., a Lantheus company. It has 1 package NDC, shown above in 10- and 11-digit form.

Lantheus Biosciences Ltd., a Lantheus company, NDC labeler code 54828. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Neuraceq?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Neuraceq NDC 54828-001 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)54828-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54828-0001Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
54828-001-50	54828000150	1 VIAL, MULTI-DOSE in 1 CONTAINER (54828-001-50) / 50 mL in 1 VIAL, MULTI-DOSEMarketed from Jun 13, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Neuraceq
Generic name (nonproprietary): florbetaben f 18
Active ingredients: Florbetaben f-18 — 135 mCi/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Lantheus Biosciences Ltd., a Lantheus companyNDC labeler code 54828
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 204677
Marketing start: Mar 20, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Positron Emitting Activity (Mechanism)
Identifiers: Product ID 54828-001_575ec63f-8d1a-c299-e063-6394a90a6c37SPL ID 575ec63f-8d1a-c299-e063-6394a90a6c37SPL set ID b0915068-cfd4-4d72-b9f8-7e31fe83cd1eUNII TLA7312TOI
Pharmacologic class: Radioactive Diagnostic Agent

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N454828000150 followed by a unit qualifier and the quantity

Package 54828-0001-50. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jul 24, 2026.

Indications (excerpt from the label)

NEURACEQ 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 fo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54828-001

What is NDC 54828-001?: 54828-001 is the product NDC for Neuraceq (florbetaben f 18), Florbetaben f-18 135 mCi/mL injection, solution, listed with the FDA by Lantheus Biosciences Ltd., a Lantheus company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Neuraceq (Florbetaben F 18).
What is the active ingredient?: Florbetaben f-18.
Who is the labeler?: Lantheus Biosciences Ltd., a Lantheus company, NDC labeler code 54828. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Neuraceq?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Neuraceq (Florbetaben f 18) NDC 54828-001