Home NDC 74725-100 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 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 N214032-001 ILLUCCIX GALLIUM GA-68 GOZETOTIDE N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17
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 N214032-001 11027031 2035-07-28 U-3317 2022-03-04
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 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214032-001 ILLUCCIX 6.7mCi/ML POWDER / INTRAVENOUS RLD, RS 2021-12-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214032-001 ILLUCCIX 6.7mCi/ML POWDER / INTRAVENOUS RLD, RS 2021-12-17 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214032-001 ILLUCCIX N/A POWDER / INTRAVENOUS RLD, RS 2021-12-17 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 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 4b0b4de00fa7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214032-001 11027031 2035-07-28 U-3317 2022-03-04 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base ILLUCCIX
Listing expiration 2027-12-31 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 74725-100-25 ILLUCCIX 1 in 1 CARTON KIT 1 15 74725-100-64 ILLUCCIX 1 in 1 CARTON KIT 1 15 74725-101-25 ILLUCCIX 1 in 1 VIAL, MULTI-DOSE INJECTION, POWDER, LYOPHILIZED, 1 25 ug 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 74725-100 ILLUCCIX (KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION) KIT [TELIX PHARMACEUTICALS (US) INC.] 9 Current NDC, Legacy NDC, 3 package rows 20241010_d4643b31-9b4f-673f-e053-2a95a90a559d.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ILLUCCIX KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION Telix Pharmaceuticals (US) Inc. d4643b31-9b4f-673f-e053-2a95a90a559d 2026-06-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 214032 application number: NDA214032 ndc (product): 74725-100
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 74725-100-25 74725010025 1 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 kit 2021-12-17 0000-00-00 No No Current 74725-100-64 74725010064 1 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 kit 2021-12-17 0000-00-00 No No Current 74725-101-25 74725010125 1 in 1 VIAL, MULTI-DOSE Historical