FDA.reportPublic FDA data

NDC 84552-501 - Gozellix

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
84552-501
Package NDCs from labels
84552-501-25
Manufacturer
Telix Innovations SA | TELIX PHARMACEUTICALS (US) INC.
Effective date
2025-04-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gozellix - Telix Innovations SA | TELIX PHARMACEUTICALS (US) INC.Telix Innovations SA | TELIX PHARMACEUTICALS (US) INC.2025-04-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84552-501GOZELLIX (GOZETOTIDE) KIT [TELIX INNOVATIONS SA]2Unmatched20250423_abeab169-e38e-433a-b8a9-f1dab31518c8.zip