Home NDC 69945-064 Detectnet
Product NDC 69945-064
11-digit product format 699450064
Labeler code 69945
Product ID 69945-064_2d08d179-39bb-5cd0-e063-6394a90a8ab0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name copper Cu 64 Dotatate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler CURIUM US LLC
Application NDA213227
Marketing category NDA
Marketing start 2020-09-14
Substance COPPER OXODOTREOTIDE CU-64
Active strength 1 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 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 N213227-001 DETECTNET COPPER CU-64 DOTATATE 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213227-001 10159759 2032-08-23 U-2951 2020-10-01 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 N213227-001 10383961 2033-07-02 U-2951 2020-10-01 N213227-001 12102696 2041-09-03 Drug product 2024-10-23
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213227-001 ODE-317 2027-09-03
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 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 116 observed states.
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 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213227-001 10383961 2033-07-02 U-2951 2020-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213227-001 12102696 2041-09-03 Drug product 2024-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213227-001 10383961 2033-07-02 U-2951 2020-10-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213227-001 12102696 2041-09-03 Drug product 2024-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213227-001 10383961 2033-07-02 U-2951 2020-10-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213227-001 12102696 2041-09-03 Drug product 2024-10-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213227-001 10383961 2033-07-02 U-2951 2020-10-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213227-001 12102696 2041-09-03 Drug product 2024-10-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213227-001 10383961 2032-08-23 U-2951 2020-10-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213227-001 12102696 2041-09-03 Drug product 2024-10-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213227-001 10383961 2032-08-23 U-2951 2020-10-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213227-001 12102696 2041-09-03 Drug product 2024-10-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213227-001 10383961 2032-08-23 U-2951 2020-10-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213227-001 12102696 2041-09-03 Drug product 2024-10-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213227-001 10383961 2032-08-23 U-2951 2020-10-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213227-001 10383961 2032-08-23 U-2951 2020-10-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213227-001 12102696 2041-09-03 Drug product 2024-10-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213227-001 10383961 2032-08-23 U-2951 2020-10-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213227-001 10383961 2032-08-23 U-2951 2020-10-01 79d66fd596c7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 70 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Detectnet
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COPPER OXODOTREOTIDE CU-64 1 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N3858377KC 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 69945-064-01 Detectnet 1 in 1 CAN INJECTION, SOLUTION 1 5 69945-064-01 Detectnet 4 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 4 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69945-064 DETECTNET (COPPER CU 64 DOTATATE) INJECTION, SOLUTION [CURIUM US LLC] 5 Current NDC, Legacy NDC, 2 package rows 20250202_f898c8a7-beb7-4318-a8ea-6f058d69342b.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 Marketing start Marketing end Sample Exclude flag Status 69945-064-01 69945006401 1 VIAL, SINGLE-USE in 1 CAN (69945-064-01) / 4 mL in 1 VIAL, SINGLE-USE 2020-09-14 0000-00-00 No No Current