FDA.reportPublic FDA data

ILLUCCIX

Product NDC
74725-100
11-digit product format
747250100
Labeler code
74725
Product ID
74725-100_4690876d-42c7-b339-e063-6394a90aea4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Kit for the preparation of gallium Ga 68 gozetotide injection
Dosage form
KIT
Route
INTRAVENOUS
Labeler
Telix Pharmaceuticals (US) Inc.
Application
NDA214032
Marketing category
NDA
Marketing start
2021-12-17
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ILLUCCIX
Listing expiration
2026-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
992a1833-9957-43c6-9b91-c0feb8613f61Product name120260107
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74725-100-25ILLUCCIX1 in 1 CARTONKIT115
74725-100-64ILLUCCIX1 in 1 CARTONKIT115
74725-101-25ILLUCCIX1 in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,125 ug15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74725-100ILLUCCIX (KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION) KIT [TELIX PHARMACEUTICALS (US) INC.]9Current NDC, Legacy NDC, 3 package rows20241010_d4643b31-9b4f-673f-e053-2a95a90a559d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
74725-100-25747250100251 KIT in 1 CARTON (74725-100-25) * 2.5 mL in 1 VIAL, MULTI-DOSE (74725-102-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (74725-103-64) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (74725-101-25) 1 kit2021-12-170000-00-00NoNoCurrent
74725-100-64747250100641 KIT in 1 CARTON (74725-100-64) * 2.5 mL in 1 VIAL, MULTI-DOSE (74725-102-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (74725-103-64) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (74725-101-25) 1 kit2021-12-170000-00-00NoNoCurrent
74725-101-25747250101251 in 1 VIAL, MULTI-DOSEHistorical