Home NDC 84552-500-25 Gozellix
Product NDC 84552-500
Requested package NDC 84552-500-25
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219592-001 GOZELLIX GALLIUM GA-68 GOZETOTIDE N/A POWDER / INTRAVENOUS RLD, RS 2025-03-20
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219592-001 11027031 2035-07-28 U-3317 2025-04-04
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N219592-001 GOZELLIX N/A POWDER / INTRAVENOUS RLD, RS 2025-03-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219592-001 GOZELLIX N/A POWDER / INTRAVENOUS RLD, RS 2025-03-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219592-001 GOZELLIX N/A POWDER / INTRAVENOUS RLD, RS 2025-03-20 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219592-001 GOZELLIX N/A POWDER / INTRAVENOUS RLD, RS 2025-03-20 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N219592-001 11027031 2035-07-28 U-3317 2025-04-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219592-001 11027031 2035-07-28 U-3317 2025-04-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219592-001 11027031 2035-07-28 U-3317 2025-04-04 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219592-001 11027031 2035-07-28 U-3317 2025-04-04 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Gozellix
Listing expiration 2026-12-31 Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84552-500-25 Gozellix 1 in 1 CARTON KIT 1 2 84552-500-64 Gozellix 1 in 1 CARTON KIT 1 2 84552-501-25 Gozellix 1 in 1 VIAL, MULTI-DOSE POWDER, FOR SOLUTION 1 25 mg 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84552-500 GOZELLIX (GOZETOTIDE) KIT [TELIX INNOVATIONS SA] 2 Current NDC, 3 package rows 20250423_abeab169-e38e-433a-b8a9-f1dab31518c8.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84552-500-25 84552050025 1 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 kit 2025-03-20 No No Current