flyrcado

Generic: flurpiridaz f-18

Labeler: ge healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name flyrcado
Generic Name flurpiridaz f-18
Labeler ge healthcare inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

flurpiridaz f-18 55 mCi/mL

Manufacturer
GE Healthcare Inc.

Identifiers & Regulatory

Product NDC 0407-8787
Product ID 0407-8787_e3534524-e1d8-4c93-9d28-66670c89d66f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215168
Listing Expiration 2027-12-31
Marketing Start 2025-02-19

Pharmacologic Class

Established (EPC)
radioactive diagnostic agent [epc]
Mechanism of Action
positron emitting activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04078787
Hyphenated Format 0407-8787

Supplemental Identifiers

UNII
TY3V24C029
NUI
N0000177914 N0000175869

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name flyrcado (source: ndc)
Generic Name flurpiridaz f-18 (source: ndc)
Application Number NDA215168 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 55 mCi/mL
source: ndc
Packaging
  • 30 mL in 1 VIAL, GLASS (0407-8787-01)
source: ndc

Packages (1)

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

Ingredients (1)

flurpiridaz f-18 (55 mCi/mL)

Linked Drug Pages (1)

Flyrcado ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e3534524-e1d8-4c93-9d28-66670c89d66f", "openfda": {"nui": ["N0000177914", "N0000175869"], "unii": ["TY3V24C029"], "spl_set_id": ["3bb6caf8-ac98-46c7-a9f0-961e66032705"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Positron Emitting Activity [MoA]"], "manufacturer_name": ["GE Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 VIAL, GLASS (0407-8787-01)", "package_ndc": "0407-8787-01", "marketing_start_date": "20250219"}], "brand_name": "Flyrcado", "product_id": "0407-8787_e3534524-e1d8-4c93-9d28-66670c89d66f", "dosage_form": "INJECTION", "pharm_class": ["Positron Emitting Activity [MoA]", "Radioactive Diagnostic Agent [EPC]"], "product_ndc": "0407-8787", "generic_name": "FLURPIRIDAZ F-18", "labeler_name": "GE Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flyrcado", "active_ingredients": [{"name": "FLURPIRIDAZ F-18", "strength": "55 mCi/mL"}], "application_number": "NDA215168", "marketing_category": "NDA", "marketing_start_date": "20250219", "listing_expiration_date": "20271231"}