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United States · US · US:0407-8787_40cd7563-6ae4-4f6b-8af9-45ad8b2427ed

Flyrcado

Orange BookUNIISPLATC V09GX

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerGE Healthcare Inc.
CountryUS (United States)
ATC codeV09GX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0407878701
    30 mL in 1 VIAL, GLASS (0407-8787-01)

Annotations

UNII (FDA Substance ID)
TY3V24C029
FLURPIRIDAZ F-18
Orange Book
N215168
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "TY3V24C029",
    "rxcui": null,
    "inchikey": "RMXZKEPDYBTFOS-LRFGSCOBSA-N",
    "display_name": "FLURPIRIDAZ F-18",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "3bb6caf8-ac98-46c7-a9f0-961e66032705": {
      "match": "brand_token",
      "title": "FLYRCADO (FLURPIRIDAZ F-18) INJECTION [GE HEALTHCARE INC.]",
      "spl_version": "25",
      "published_date": "2026-03-18"
    }
  },
  "productid": "0407-8787_40cd7563-6ae4-4f6b-8af9-45ad8b2427ed",
  "productndc": "0407-8787",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "215168",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5-55mCi/ML",
        "product_no": "001",
        "approval_date": "Sep 27, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLURPIRIDAZ F-18",
  "proprietary_name": "Flyrcado",
  "active_ingred_unit": "mCi/mL",
  "application_number": "NDA215168",
  "marketing_category": "NDA",
  "nonproprietary_name": "FLURPIRIDAZ F-18",
  "start_marketing_date": "20250219",
  "active_numerator_strength": "55"
}

Related drugs

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