Home NDC 0078-1224 LOCAMETZ
Product NDC 0078-1224
11-digit product format 000781224
Labeler code 0078
Product ID 0078-1224_8683b06e-4901-4526-89ad-23a8fe2d1331
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name kit for the preparation of gallium Ga 68 gozetotide
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Novartis Pharmaceuticals Corporation
Application NDA215841
Marketing category NDA
Marketing start 2022-03-23
Substance GOZETOTIDE
Active strength 25 ug/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N215841-001 LOCAMETZ GALLIUM GA-68 GOZETOTIDE N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 N215841-001 12109277 2036-03-09 U-4002 2024-10-08
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 2026-09-14 22:38:34 2026-08 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 5d02ea3f76ae…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215841-001 LOCAMETZ N/A POWDER / INTRAVENOUS RLD, RS 2022-03-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215841-001 12109277 2036-03-09 U-4002 2024-10-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215841-001 12109277 2036-03-09 U-4002 2024-10-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215841-001 12109277 2036-03-09 U-4002 2024-10-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215841-001 12109277 2036-03-09 U-4002 2024-10-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215841-001 12109277 2036-03-09 U-4002 2024-10-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215841-001 12109277 2036-03-09 U-4002 2024-10-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215841-001 12109277 2036-03-09 U-4002 2024-10-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215841-001 12109277 2036-03-09 U-4002 2024-10-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215841-001 12109277 2036-03-09 U-4002 2024-10-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215841-001 12109277 2036-03-09 U-4002 2024-10-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215841-001 12109277 2036-03-09 U-4002 2024-10-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215841-001 11369590 2028-08-15 U-3400 Drug substance, Drug product 2022-07-28 a50c72e98297…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base LOCAMETZ
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GOZETOTIDE 25 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9AG41L3AOQ Internal UNII lookup
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 0078-1224-61 LOCAMETZ 1 in 1 VIAL, MULTI-DOSE INJECTION, POWDER, LYOPHILIZED, 1 1 0078-1224-61 LOCAMETZ 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 1
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 LOCAMETZ KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE Novartis Pharmaceuticals Corporation 8683b06e-4901-4526-89ad-23a8fe2d1331 2026-01-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 215841 application number: NDA215841 ndc (product): 0078-1224
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0078-1224-61 00078122461 1 VIAL, MULTI-DOSE in 1 CARTON (0078-1224-61) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE 2026-01-15 No No Current