Home NDC 70510-2322 RADICAVA ORS
Product NDC 70510-2322
11-digit product format 705102322
Labeler code 70510
Product ID 70510-2322_9f9d17c0-7426-4713-885d-fb22a34b7028
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name EDARAVONE
Dosage form KIT
Labeler Shionogi Inc.
Application NDA215446
Marketing category NDA
Marketing start 2022-05-12
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 N215446-001 RADICAVA ORS EDARAVONE 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215446-001 10987341 2039-11-01 Drug product 2022-06-07 N215446-001 11241416 2039-11-01 Drug product 2022-06-07 N215446-001 11478450 2039-11-01 U-3468 2022-11-15 N215446-001 11826352 2039-11-01 Drug product 2023-12-05 N215446-001 11957660 2039-11-01 Drug product 2024-05-09 N215446-001 12285409 2039-11-01 Drug product 2025-05-06 N215446-001 12599586 2039-11-01 Drug product 2026-04-28 N215446-001 12194025 2041-11-12 U-4111 2025-02-11 N215446-001 12310946 2041-11-12 U-4111 2025-06-20 N215446-001 12478611 2041-11-12 U-4111 2025-12-18 N215446-001 12527769 2041-11-12 U-4111 2026-02-10 N215446-001 12569469 2041-11-12 U-4111 2026-03-24
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215446-001 ODE-144 2029-05-12
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 2026-08-18 06:07:40 2026-07 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215446-001 RADICAVA ORS 105MG/5ML SUSPENSION / ORAL RLD, RS 2022-05-12 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 147 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N215446-001 10987341 2039-11-01 Drug product 2022-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215446-001 11241416 2039-11-01 Drug product 2022-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215446-001 11478450 2039-11-01 U-3468 2022-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215446-001 11826352 2039-11-01 Drug product 2023-12-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215446-001 11957660 2039-11-01 Drug product 2024-05-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215446-001 12285409 2039-11-01 Drug product 2025-05-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215446-001 12599586 2039-11-01 Drug product 2026-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215446-001 12194025 2041-11-12 U-4111 2025-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215446-001 12310946 2041-11-12 U-4111 2025-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215446-001 12478611 2041-11-12 U-4111 2025-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215446-001 12527769 2041-11-12 U-4111 2026-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215446-001 12569469 2041-11-12 U-4111 2026-03-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215446-001 10987341 2039-11-01 Drug product 2022-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215446-001 11241416 2039-11-01 Drug product 2022-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215446-001 11478450 2039-11-01 U-3468 2022-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215446-001 11826352 2039-11-01 Drug product 2023-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215446-001 11957660 2039-11-01 Drug product 2024-05-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215446-001 12285409 2039-11-01 Drug product 2025-05-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215446-001 12194025 2041-11-12 U-4111 2025-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215446-001 12310946 2041-11-12 U-4111 2025-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215446-001 12478611 2041-11-12 U-4111 2025-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215446-001 12527769 2041-11-12 U-4111 2026-02-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215446-001 10987341 2039-11-01 Drug product 2022-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215446-001 11241416 2039-11-01 Drug product 2022-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215446-001 11478450 2039-11-01 U-3468 2022-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215446-001 11826352 2039-11-01 Drug product 2023-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215446-001 11957660 2039-11-01 Drug product 2024-05-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215446-001 12285409 2039-11-01 Drug product 2025-05-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215446-001 12194025 2041-11-12 U-4111 2025-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215446-001 12310946 2041-11-12 U-4111 2025-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215446-001 10987341 2039-11-01 Drug product 2022-06-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215446-001 11241416 2039-11-01 Drug product 2022-06-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215446-001 11478450 2039-11-01 U-3468 2022-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215446-001 11826352 2039-11-01 Drug product 2023-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215446-001 11957660 2039-11-01 Drug product 2024-05-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215446-001 12285409 2039-11-01 Drug product 2025-05-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215446-001 12194025 2041-11-12 U-4111 2025-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215446-001 12310946 2041-11-12 U-4111 2025-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215446-001 10987341 2039-11-01 Drug product 2022-06-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215446-001 11241416 2039-11-01 Drug product 2022-06-07 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base RADICAVA ORS
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1924316 Internal RxNorm lookup 1924317 Internal RxNorm lookup 2602117 Internal RxNorm lookup 2602122 Internal RxNorm 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 70510-2322-1 RADICAVA ORS 1 in 1 CARTON KIT 1 29 70510-2324-1 RADICAVA ORS 50 mL in 1 BOTTLE SUSPENSION 1 mL 1050 mg in 50mL 29
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70510-2322 RADICAVA (EDARAVONE) INJECTION RADICAVA ORS (EDARAVONE) KIT [MITSUBISHI TANABE PHARMA AMERICA, INC.] 24 Current NDC, Legacy NDC, 2 package rows 20250305_0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70510-2322-1 70510232201 1 KIT in 1 CARTON (70510-2322-1) * 50 mL in 1 BOTTLE (70510-2324-1) 1 kit 2022-05-12 0000-00-00 No No Current 70510-2324-1 70510232401 50 mL in 1 BOTTLE 50 ml Historical