Home NDC 0469-6501 LEXISCAN
Product NDC 0469-6501
11-digit product format 004696501
Labeler code 0469
Product ID 0469-6501_8fb5b92b-3654-43ff-98d3-3ac23c9a0b10
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name regadenoson
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Astellas Pharma US, Inc.
Application NDA022161
Marketing category NDA
Marketing start 2008-04-10
Substance REGADENOSON
Active strength .08 mg/mL
Pharmacologic classes Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [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 N022161-001 LEXISCAN REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022161-001 AP
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 5 · 172 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 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022161-001 6403567 2022-04-10 U-869 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022161-001 6403567 2022-04-10 U-869 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022161-001 6403567 2022-04-10 U-869 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022161-001 7144872 2019-06-22 U-870 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022161-001 7144872 2019-06-22 U-116 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022161-001 7144872 2019-06-22 U-869 Drug substance, Drug product 74a2ff9319b5…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base LEXISCAN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength REGADENOSON .08 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2XLN4Y044H 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 0469-6501-89 LEXISCAN 5 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 5 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0469-6501 LEXISCAN (REGADENOSON) INJECTION, SOLUTION [ASTELLAS PHARMA US, INC.] 13 Current NDC, Legacy NDC, 1 package rows 20190129_057289f4-2e18-4c1e-bed4-6c1858e2ef16.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 · 2 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 0469-6501-89 00469650189 5 mL in 1 SYRINGE, PLASTIC (0469-6501-89) 5 ml 2008-04-10 0000-00-00 No No Current