Home NDC 17156-210 DaTscan
Product NDC 17156-210
11-digit product format 171560210
Labeler code 17156
Product ID 17156-210_900b7272-7f13-43ef-9320-bc63ccc1434b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ioflupane I-123
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Medi-Physics Inc. dba GE Healthcare.
Application NDA022454
Marketing category NDA
Marketing start 2011-03-01
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N022454-001 DATSCAN IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022454-001 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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2011-01-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2011-01-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2011-01-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2011-01-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2011-01-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2011-01-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2011-01-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2011-01-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2011-01-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2011-01-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2011-01-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022454-001 DATSCAN 5mCi/2.5ML (2mCi/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-01-14 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base DaTscan
Listing expiration 2027-12-31 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 17156-210-01 DaTscan 1 in 1 CONTAINER INJECTION, SOLUTION 1 17 17156-210-01 DaTscan 2.5 mL in 1 VIAL, GLASS INJECTION, SOLUTION 2.5 17
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17156-210 DATSCAN (IOFLUPANE I-123) INJECTION, SOLUTION [MEDI-PHYSICS INC. DBA GE HEALTHCARE.] 14 Current NDC, Legacy NDC, 2 package rows 20240112_ef7804d7-c691-495b-8aaf-5bc54fd5d9f6.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DaTscan IOFLUPANE I-123 Medi-Physics Inc. dba GE Healthcare. ef7804d7-c691-495b-8aaf-5bc54fd5d9f6 2026-04-24 Warnings, Adverse reactions Exact identifier application applno (NDA): 022454 application number: NDA022454 ndc (product): 17156-210
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 17156-210-01 17156021001 1 VIAL, GLASS in 1 CONTAINER (17156-210-01) / 2.5 mL in 1 VIAL, GLASS 2011-03-01 0000-00-00 No No Current