Home NDC 69945-166 Ioflupane I 123
Product NDC 69945-166
11-digit product format 699450166
Labeler code 69945
Product ID 69945-166_c6a56613-3636-4736-bdaf-db89d8a8448b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IOFLUPANE I-123
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Curium US LLC
Application ANDA213792
Marketing category ANDA
Marketing start 2022-03-31
Substance IOFLUPANE I-123
Active strength 2 mCi/mL
Pharmacologic classes Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
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 A213792-001 IOFLUPANE I-123 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213792-001 AP
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 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 5d02ea3f76ae…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213792-001 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP 2022-03-30 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ioflupane I 123
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IOFLUPANE I-123 2 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3MM99T8R5Q 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 69945-166-05 Ioflupane I 123 2.5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2.5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69945-166 IOFLUPANE I 123 (IOFLUPANE I-123) INJECTION, SOLUTION [CURIUM US LLC] 6 Current NDC, Legacy NDC, 1 package rows 20221230_66d20aee-4530-48dd-a483-ed7604b36d97.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 69945-166-05 69945016605 2.5 mL in 1 VIAL, SINGLE-DOSE (69945-166-05) 2.5 ml 2022-03-31 0000-00-00 No No Current