FDA.reportPublic FDA data

Gozellix

Product NDC
84552-500
11-digit product format
845520500
Labeler code
84552
Product ID
84552-500_334df051-2b2d-01fe-e063-6394a90a05f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GOZETOTIDE
Dosage form
KIT
Labeler
Telix Innovations SA
Application
NDA219592
Marketing category
NDA
Marketing start
2025-03-20
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gozellix
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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84552-500-25Gozellix1 in 1 CARTONKIT12
84552-500-64Gozellix1 in 1 CARTONKIT12
84552-501-25Gozellix1 in 1 VIAL, MULTI-DOSEPOWDER, FOR SOLUTION125 mg2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84552-500-25EA - Each84552-500d215be42-b746-43df-bdb1-9a0d5b2e148c12025-09-12
84552-500-64EA - Each84552-500efdf07ee-26e2-47a0-a4c9-4cfb7aa5fb9e12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84552-500GOZELLIX (GOZETOTIDE) KIT [TELIX INNOVATIONS SA]2Current NDC, 3 package rows20250423_abeab169-e38e-433a-b8a9-f1dab31518c8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84552-500-25845520500251 KIT in 1 CARTON (84552-500-25) * 2.5 mL in 1 VIAL, MULTI-DOSE (84552-502-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (84552-503-64) * 2 mL in 1 AMPULE (84552-504-25) * 1 POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE (84552-501-25) 1 kit2025-03-20NoNoHistorical
84552-500-64845520500641 KIT in 1 CARTON (84552-500-64) * 2.5 mL in 1 VIAL, MULTI-DOSE (84552-502-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (84552-503-64) * 2 mL in 1 AMPULE (84552-504-25) * 1 POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE (84552-501-25) 1 kit2025-03-20NoNoHistorical
84552-501-25845520501251 in 1 VIAL, MULTI-DOSEHistorical