RADICAVA

Product NDC: 70510-2171
Requested package NDC: 70510-2171-2
11-digit product format: 705102171
Labeler code: 70510
Product ID: 70510-2171_5568c252-2a53-4307-8961-063865500fc6
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: 2017-05-05
Marketing end: 0000-00-00
Substance: EDARAVONE
Active strength: 30 mg/100mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70510-2171	70510-2171-2	D	Discontinued by firm		2026-08-17

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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209176-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209176-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209176-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209176-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209176-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209176-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209176-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209176-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209176-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209176-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209176-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209176-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209176-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209176-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209176-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209176-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209176-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209176-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209176-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209176-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209176-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209176-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209176-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209176-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209176-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209176-002	AP	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209176-001	ODE-144	2024-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209176-002	ODE*	2024-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209176-001	ODE-144	2024-05-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209176-002	ODE*	2024-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209176-001	ODE-144	2024-05-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209176-002	ODE*	2024-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209176-001	ODE-144	2024-05-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209176-002	ODE*	2024-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209176-001	ODE-144	2024-05-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209176-002	ODE*	2024-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209176-001	ODE-144	2024-05-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209176-002	ODE*	2024-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209176-001	ODE-144	2024-05-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209176-002	ODE*	2024-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209176-001	ODE-144	2024-05-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209176-002	ODE*	2024-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209176-001	ODE-144	2024-05-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209176-002	ODE*	2024-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209176-001	NCE	2022-05-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209176-001	ODE-144	2024-05-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209176-002	NCE	2022-05-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209176-002	ODE*	2024-05-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209176-001	NCE	2022-05-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209176-001	ODE-144	2024-05-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209176-002	NCE	2022-05-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209176-002	ODE*	2024-05-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209176-001	NCE	2022-05-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209176-001	ODE-144	2024-05-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209176-002	NCE	2022-05-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209176-002	ODE*	2024-05-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209176-001	NCE	2022-05-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209176-001	ODE-144	2024-05-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209176-001	NCE	2022-05-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209176-001	ODE-144	2024-05-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209176-002	NCE	2022-05-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209176-002	ODE*	2024-05-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209176-001	NCE	2022-05-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209176-001	ODE-144	2024-05-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209176-002	NCE	2022-05-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209176-002	ODE*	2024-05-05	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
385a0d1f-d345-4dbf-ab81-b84027f8102f	Product name	3	20250218
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
2e254488-9fcb-41b3-a7c3-e2c9a3941b29	Product name	1	20200603
b4ff0805-126a-406d-9cae-fc34fd8e8889	Product name	1	20190711
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2020-03-12	These highlights do not include all the information needed to use RADICAVA or RADICAVA ORS safely and effectively. See full prescribing information for RADICAVA or RADICAVA ORS . RADICAVA® (edaravone) injection, for intravenous use RADICAVA ORS® (edaravone) oral suspension Initial U.S. Approval: 2017
2020-03-12	These highlights do not include all the information needed to use RADICAVA or RADICAVA ORS safely and effectively. See full prescribing information for RADICAVA or RADICAVA ORS . RADICAVA® (edaravone) injection, for intravenous use RADICAVA ORS® (edaravone) oral suspension Initial U.S. Approval: 2017
2020-03-12	These highlights do not include all the information needed to use RADICAVA or RADICAVA ORS safely and effectively. See full prescribing information for RADICAVA or RADICAVA ORS. RADICAVA ® (edaravone) injection, for intravenous use RADICAVA ORS ® (edaravone) oral suspension Initial U.S. Approval: 2017
2020-01-31	These highlights do not include all the information needed to use RADICAVA or RADICAVA ORS safely and effectively. See full prescribing information for RADICAVA or RADICAVA ORS . RADICAVA® (edaravone) injection, for intravenous use RADICAVA ORS® (edaravone) oral suspension Initial U.S. Approval: 2017
2020-01-31	These highlights do not include all the information needed to use RADICAVA or RADICAVA ORS safely and effectively. See full prescribing information for RADICAVA or RADICAVA ORS . RADICAVA® (edaravone) injection, for intravenous use RADICAVA ORS® (edaravone) oral suspension Initial U.S. Approval: 2017
2020-01-31	These highlights do not include all the information needed to use RADICAVA or RADICAVA ORS safely and effectively. See full prescribing information for RADICAVA or RADICAVA ORS. RADICAVA ® (edaravone) injection, for intravenous use RADICAVA ORS ® (edaravone) oral suspension Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70510-2171-1	RADICAVA	100 mL in 1 BAG	INJECTION	100		29
70510-2171-2	RADICAVA	2 in 1 CARTON	INJECTION	2		29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70510-2171-1	ML - Milliliter	70510-2171	2f6a6236-deaa-4b97-bb50-a7ff734ed1b2	1	2017-06-15
70510-2171-2	ML - Milliliter	70510-2171	55c52454-7ae7-4bf0-aa56-455b980ca26a	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70510-2171	RADICAVA (EDARAVONE) INJECTION RADICAVA ORS (EDARAVONE) KIT [MITSUBISHI TANABE PHARMA AMERICA, INC.]	24	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RADICAVA ORS	EDARAVONE	Shionogi Inc.	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	2026-05-05	Warnings, Adverse reactions	Exact identifier ndc (package): 70510-2171-2 ndc (product): 70510-2171 ndc11 (package): 70510217102

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S798V6YJRP	EDARAVONE	89-25-8	EDARAVONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2602117	edaravone 21 MG/mL Oral Suspension	PSN	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	29
1924316	edaravone 30 MG in 100 ML Injection	PSN	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	29
1924317	Radicava 30 MG in 100 ML Injection	PSN	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	29
2602122	Radicava ORS 21 MG/mL Oral Suspension	PSN	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	29
1924317	100 ML edaravone 0.3 MG/ML Injection [Radicava]	SBD	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	29
2602122	edaravone 21 MG/ML Oral Suspension [Radicava]	SBD	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	29
1924316	100 ML edaravone 0.3 MG/ML Injection	SCD	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	29
2602117	edaravone 21 MG/ML Oral Suspension	SCD	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	29
1924317	100 ML Radicava 0.3 MG/ML Injection	SY	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	29
2602117	edaravone 1050 MG per 50 ML Oral Suspension	SY	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	29
1924316	edaravone 30 MG per 100 ML Injection	SY	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	29
2602117	edaravone 735 MG per 35 ML Oral Suspension	SY	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	29
1924317	Radicava 30 MG per 100 ML Injection	SY	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	29
2602122	Radicava ORS 1050 MG per 50 ML Oral Suspension	SY	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	29
2602122	Radicava ORS 21 MG/ML Oral Suspension	SY	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	29
2602122	Radicava ORS 735 MG per 35 ML Oral Suspension	SY	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	29

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70510-2171-2	70510217102	2 BAG in 1 CARTON (70510-2171-2) > 100 mL in 1 BAG (70510-2171-1)	2 bag	2017-05-05	0000-00-00	No	No	Current