Home NDC 70510-2172 RADICAVA
Product NDC 70510-2172
11-digit product format 705102172
Labeler code 70510
Product ID 70510-2172_df6522ed-2347-488b-8f75-9ec8e60ca28a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name edaravone
Dosage form INJECTION
Route INTRAVENOUS
Labeler Mitsubishi Tanabe Pharma America, Inc.
Application NDA209176
Marketing category NDA
Marketing start 2020-05-05
Marketing end 0000-00-00
Substance EDARAVONE
Active strength 60 mg/100mL
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70510-2172-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70510-2172-1 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209176-001 RADICAVA EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD 2017-05-05 N209176-002 RADICAVA EDARAVONE 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS RLD 2018-11-15
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 3 · 84 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 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD 2017-05-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS RLD 2018-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD 2017-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD 2018-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD 2017-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD 2018-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-05-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-05-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-05-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-11-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-05-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-11-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-05-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-11-15 bb7c543d1eb4…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N209176-001 6933310 2020-11-13 U-2013 2017-05-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N209176-002 6933310 2020-11-13 U-2013 2018-12-04 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N209176-001 6933310 2020-11-13 U-2013 2017-05-31 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N209176-002 6933310 2020-11-13 U-2013 2018-12-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209176-001 6933310 2020-11-13 U-2013 2017-05-31 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N209176-002 6933310 2020-11-13 U-2013 2018-12-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209176-001 6933310 2020-11-13 U-2013 2017-05-31 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N209176-002 6933310 2020-11-13 U-2013 2018-12-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209176-001 6933310 2020-11-13 U-2013 2017-05-31 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N209176-002 6933310 2020-11-13 U-2013 2018-12-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209176-001 6933310 2020-11-13 U-2013 2017-05-31 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N209176-002 6933310 2020-11-13 U-2013 2018-12-04 ea99ee380514…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 95 observed states.