FDA.reportPublic FDA data

Flyrcado

Product NDC
0407-8787
11-digit product format
004078787
Labeler code
0407
Product ID
0407-8787_40cd7563-6ae4-4f6b-8af9-45ad8b2427ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLURPIRIDAZ F-18
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
GE Healthcare Inc.
Application
NDA215168
Marketing category
NDA
Marketing start
2025-02-19
Substance
FLURPIRIDAZ F-18
Active strength
55 mCi/mL
Pharmacologic classes
Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Flyrcado
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLURPIRIDAZ F-1855 mCi/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTY3V24C029

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
153e5130-0f3b-4191-a2be-e091e6910a70Product name120250423
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0407-8787-01Flyrcado30 mL in 1 VIAL, GLASSINJECTION3025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0407-8787-01EA - Each0407-8787901073cd-0bc6-4ff6-ab31-0424d71b6acd12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0407-8787FLYRCADO (FLURPIRIDAZ F-18) INJECTION [GE HEALTHCARE]7Current NDC, 1 package rows20250221_3bb6caf8-ac98-46c7-a9f0-961e66032705.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0407-8787-010040787870130 mL in 1 VIAL, GLASS (0407-8787-01) 30 ml2025-02-19NoNoCurrent