edaravone

Product NDC: 39822-4500
11-digit product format: 398224500
Labeler code: 39822
Product ID: 39822-4500_316d0e19-cb92-1e55-e063-6294a90ab687
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: edaravone
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: XGen Pharmaceuticals DJB, Inc.
Application: ANDA217565
Marketing category: ANDA
Marketing start: 2024-12-02
Substance: EDARAVONE
Active strength: 30 mg/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	39822-4500		D	Discontinued by firm		2026-08-17
excluded package	package	39822-4500	39822-4500-2	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
A217565-001	EDARAVONE	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION / INTRAVENOUS			2024-10-31
A217565-002	EDARAVONE	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS			2024-10-31

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	A217565-001	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION / INTRAVENOUS			2024-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217565-002	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS			2024-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217565-001	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION / INTRAVENOUS	AP		2024-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217565-002	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2024-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217565-001	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION / INTRAVENOUS	AP		2024-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217565-002	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2024-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217565-001	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION / INTRAVENOUS	AP		2024-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217565-002	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP		2024-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217565-001	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION / INTRAVENOUS	AP		2024-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217565-002	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP		2024-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217565-001	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION / INTRAVENOUS	AP		2024-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217565-002	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP		2024-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217565-001	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION / INTRAVENOUS	AP		2024-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217565-002	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP		2024-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217565-001	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION / INTRAVENOUS	AP		2024-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217565-002	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP		2024-10-31	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217565-001	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION / INTRAVENOUS	AP		2024-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217565-002	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP		2024-10-31	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217565-001	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION / INTRAVENOUS			2024-10-31	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217565-002	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS			2024-10-31	`a50c72e98297…`

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	A217565-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217565-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217565-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217565-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217565-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217565-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217565-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217565-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217565-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217565-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217565-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217565-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217565-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217565-002	AP	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217565-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217565-002	AP	1	`d8e5a09893c0…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
385a0d1f-d345-4dbf-ab81-b84027f8102f	Product name	3	20250218
2e254488-9fcb-41b3-a7c3-e2c9a3941b29	Product name	1	20200603
b4ff0805-126a-406d-9cae-fc34fd8e8889	Product name	1	20190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
39822-4500-1	edaravone	100 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	100		4
39822-4500-2	edaravone	2 in 1 CARTON	INJECTION, SOLUTION	2		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
39822-4500-1	ML - Milliliter	39822-4500	39130e66-1153-49ba-b5ee-2d6cc5b2f5f0	1	2024-12-10
39822-4500-2	ML - Milliliter	39822-4500	d2471f03-c136-40b3-80b2-adf804ec94d2	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
39822-4500	EDARAVONE INJECTION, SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]	3	Current NDC, 2 package rows	20250424_a8245a98-2ccb-4062-b865-3aa348351b48.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
edaravone	EDARAVONE	XGen Pharmaceuticals DJB, Inc.	a8245a98-2ccb-4062-b865-3aa348351b48	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217565 application number: ANDA217565 ndc (product): 39822-4500

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
1924316	edaravone 30 MG in 100 ML Injection	PSN	a8245a98-2ccb-4062-b865-3aa348351b48	4
2681044	edaravone 60 MG in 100 ML Injection	PSN	a8245a98-2ccb-4062-b865-3aa348351b48	4
1924316	100 ML edaravone 0.3 MG/ML Injection	SCD	a8245a98-2ccb-4062-b865-3aa348351b48	4
2681044	100 ML edaravone 0.6 MG/ML Injection	SCD	a8245a98-2ccb-4062-b865-3aa348351b48	4
1924316	edaravone 30 MG per 100 ML Injection	SY	a8245a98-2ccb-4062-b865-3aa348351b48	4
2681044	edaravone 60 MG per 100 ML Injection	SY	a8245a98-2ccb-4062-b865-3aa348351b48	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
39822-4500-1	39822450001	100 mL in 1 VIAL, SINGLE-DOSE	100 ml				Historical
39822-4500-2	39822450002	2 VIAL, SINGLE-DOSE in 1 CARTON (39822-4500-2) / 100 mL in 1 VIAL, SINGLE-DOSE (39822-4500-1)		2024-12-02	No	No	Historical