Home NDC 76394-2642 Gallium Ga-68 PSMA-11
Product NDC 76394-2642
11-digit product format 763942642
Labeler code 76394
Product ID 76394-2642_2784e7a8-d4f1-fa61-e063-6394a90a614e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name GALLIUM GA-68 GOZETOTIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler UCLA Biomedical Cyclotron
Application NDA212642
Marketing category NDA
Marketing start 2020-12-09
Substance GALLIUM GA-68 GOZETOTIDE
Active strength 5 mCi/mL
Pharmacologic classes Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]
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 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 N212642-001 GALLIUM GA 68 GOZETOTIDE GALLIUM GA-68 GOZETOTIDE 0.5-5mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2020-12-01
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 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212642-001 GALLIUM GA 68 PSMA-11 30ML (0.5-5mCi/mL) SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212642-001 GALLIUM GA 68 PSMA-11 30ML (0.5-5mCi/mL) SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212642-001 GALLIUM GA 68 PSMA-11 30ML (0.5-5mCi/mL) SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212642-001 GALLIUM GA 68 PSMA-11 30ML (0.5-5mCi/mL) SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212642-001 GALLIUM GA 68 PSMA-11 30ML (0.5-5MCI/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212642-001 GALLIUM GA 68 PSMA-11 30ML (0.5-5MCI/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212642-001 GALLIUM GA 68 PSMA-11 30ML (0.5-5MCI/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212642-001 GALLIUM GA 68 GOZETOTIDE 30ML (0.5-5mCi/mL) SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 66 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Gallium Ga-68 PSMA-11
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GALLIUM GA-68 GOZETOTIDE 5 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ZJ0EKR6M10 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76394-2642-3 Gallium Ga-68 PSMA-11 12 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 12 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76394-2642 GALLIUM GA-68 PSMA-11 (GALLIUM GA-68 GOZETOTIDE) INJECTION, SOLUTION [UCLA BIOMEDICAL CYCLOTRON] 6 Current NDC, Legacy NDC, 1 package rows 20241123_7744bafb-755e-29a2-e053-2991aa0a86a9.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 Marketing end Sample Exclude flag Status 76394-2642-3 76394264203 12 mL in 1 VIAL, MULTI-DOSE (76394-2642-3) 12 ml 2020-12-09 0000-00-00 No No Current