Home NDC 24417-681 Ga-68-DOTATOC
Product NDC 24417-681
11-digit product format 244170681
Labeler code 24417
Product ID 24417-681_d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name EDOTREOTIDE GALLIUM GA-68
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler UIHC � P E T Imaging Center
Application NDA210828
Marketing category NDA
Marketing start 2019-09-01
Substance EDOTREOTIDE GALLIUM GA-68
Active strength 4 mCi/mL
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 N210828-001 GALLIUM GA 68 EDOTREOTIDE GALLIUM GA-68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS AP RLD, RS 2019-08-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N210828-001 AP
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210828-001 ODE-383 2026-08-21 N210828-001 W 2026-08-21
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 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS AP RLD, RS 2019-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS AP RLD, RS 2019-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210828-001 GALLIUM DOTATOC GA 68 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210828-001 GALLIUM DOTATOC GA 68 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210828-001 GALLIUM DOTATOC GA 68 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210828-001 GALLIUM DOTATOC GA 68 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210828-001 GALLIUM DOTATOC GA 68 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210828-001 GALLIUM DOTATOC GA 68 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210828-001 GALLIUM DOTATOC GA 68 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210828-001 GALLIUM DOTATOC GA 68 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210828-001 GALLIUM DOTATOC GA 68 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210828-001 GALLIUM DOTATOC GA 68 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210828-001 GALLIUM DOTATOC GA 68 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210828-001 GALLIUM DOTATOC GA 68 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210828-001 GALLIUM GA 68 DOTATOC 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210828-001 GALLIUM GA 68 DOTATOC 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210828-001 GALLIUM GA 68 DOTATOC 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210828-001 GALLIUM GA 68 DOTATOC 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210828-001 GALLIUM GA 68 DOTATOC 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210828-001 GALLIUM GA 68 DOTATOC 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210828-001 GALLIUM DOTATOC GA 68 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210828-001 GALLIUM DOTATOC GA 68 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS AP RLD, RS 2019-08-21 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210828-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210828-001 AP 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210828-001 AP 1 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 128 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ga-68-DOTATOC
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EDOTREOTIDE GALLIUM GA-68 4 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Y68179SY2L 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 24417-681-30 Ga-68-DOTATOC 14 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 14 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24417-681 GA-68-DOTATOC (EDOTREOTIDE GALLIUM GA-68) INJECTION, SOLUTION [UIHC – P E T IMAGING CENTER] 3 Current NDC, Legacy NDC, 1 package rows 20211212_c4d185c3-d520-462d-ba50-4f4ee485ace3.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 24417-681-30 24417068130 14 mL in 1 VIAL, MULTI-DOSE (24417-681-30) 14 ml 2019-09-01 0000-00-00 No No Current