Neuraceq

Orange BookUNIISPLATC V09AX06

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerLantheus Biosciences Ltd.

CountryUS (United States)

ATC codeV09AX06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

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

Annotations

UNII (FDA Substance ID)

TLA7312TOI

FLORBETABEN F-18

RxCUI 1492940

Orange Book

N204677

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "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"
}

Related drugs

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