United States· US:54828-001_4bcfe123-9c5b-2f90-e063-6294a90aaa46

Neuraceq

A florbetaben (18f) product containing florbetaben f 18, registered in United States by Lantheus Biosciences Ltd.. The same ATC class is registered in 11 of our 19 countries.

ATC V09AX06Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedNeuraceqATCV09AX06REGISTER NO.US:54828-001_4bcfe123…PACKS LISTED1CHECKEDJune 3, 2026

Where it is registered

Florbetaben (18f) is registered in 11 of 19 countries.

Countries holding a registration under ATC V09AX06 (florbetaben (18f)), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 7 of them publish a price we can compare per daily dose

Florbetaben (18f) · ATC V09AX06

11 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Polandprice
  • Switzerlandprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Florbetaben F 18
Manufacturer
Lantheus Biosciences Ltd.
Country
United States (US)
ATC code
V09AX06
ATC class
Florbetaben (18F)
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    5482800150
    1 VIAL, MULTI-DOSE in 1 CONTAINER (54828-001-50) / 50 mL in 1 VIAL, MULTI-DOSE

Regulatory notes

UNII (FDA substance ID)
TLA7312TOI
FLORBETABEN F-18
RxCUI 1492940
Orange Book
N204677
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Florbetaben (18f) in 8 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All florbetaben (18f) products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Neuraceq
  • Liechtenstein · Neuraceq
  • Norway · Neuraceq

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/a0462475-7b08-4ef6-a351-e15167b5bc2d
GET /v1/drugs/a0462475-7b08-4ef6-a351-e15167b5bc2d?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "TLA7312TOI",
    "rxcui": "1492940",
    "inchikey": "NCWZOASIUQVOFA-FWZJPQCDSA-N",
    "display_name": "FLORBETABEN F-18",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "b0915068-cfd4-4d72-b9f8-7e31fe83cd1e": {
      "match": "brand_token",
      "title": "NEURACEQ (FLORBETABEN F 18) INJECTION, SOLUTION [LANTHEUS BIOSCIENCES LTD.]",
      "spl_version": "41",
      "published_date": "2026-03-02"
    }
  },
  "productid": "54828-001_4bcfe123-9c5b-2f90-e063-6294a90aaa46",
  "productndc": "54828-001",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "204677",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.4-135mCi/ML",
        "product_no": "001",
        "approval_date": "Mar 19, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLORBETABEN F-18",
  "proprietary_name": "Neuraceq",
  "active_ingred_unit": "mCi/mL",
  "application_number": "NDA204677",
  "marketing_category": "NDA",
  "nonproprietary_name": "Florbetaben F 18",
  "start_marketing_date": "20140320",
  "active_numerator_strength": "135"
}

See everything about florbetaben (18f).

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.