ONGENTYS

Product NDC: 70370-3025
11-digit product format: 703703025
Labeler code: 70370
Product ID: 70370-3025_62cbc1fe-da3b-436f-ba28-5dca7becb528
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: opicapone
Dosage form: CAPSULE
Route: ORAL
Labeler: Neurocrine Biosciences, Inc.
Application: NDA212489
Marketing category: NDA
Marketing start: 2020-04-24
Marketing end: 0000-00-00
Substance: OPICAPONE
Active strength: 25 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70370-3025		D	Discontinued by firm		2026-10-05
excluded package	package	70370-3025	70370-3025-2	D	Discontinued by firm		2026-10-05

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 · 22 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	70370-3025-2	`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	70370-3025-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70370-3025-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70370-3025-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70370-3025-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70370-3025-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70370-3025-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70370-3025-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70370-3025-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70370-3025-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70370-3025-2	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N212489-001	ONGENTYS	OPICAPONE	25MG	CAPSULE / ORAL		RLD	2020-04-24
N212489-002	ONGENTYS	OPICAPONE	50MG	CAPSULE / ORAL		RLD, RS	2020-04-24

Orange Book patents#

Current patent rows page 1 of 1 · 22 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212489-001	9550759	2026-07-26	U-3870		2020-05-19
N212489-001	9550759	2026-07-26	U-3871		2020-05-19
N212489-001	9550759	2026-07-26	U-3872		2020-05-19
N212489-001	8907099	2027-05-12		Drug substance	2020-05-19
N212489-001	8168793	2027-10-10	U-3869	Drug substance, Drug product	2020-05-19
N212489-001	9745290	2027-10-10	U-3869	Drug product	2020-05-19
N212489-001	8524746	2029-07-14	U-3869		2020-05-19
N212489-001	10071085	2030-03-31		Drug product	2020-05-19
N212489-001	10583130	2030-03-31	U-3869		2020-05-19
N212489-001	12129247	2032-01-11	U-4038		2024-11-26
N212489-001	9630955	2032-12-12	U-3869	Drug substance, Drug product	2020-05-19
N212489-002	9550759	2026-07-26	U-3870		2020-05-19
N212489-002	9550759	2026-07-26	U-3871		2020-05-19
N212489-002	9550759	2026-07-26	U-3872		2020-05-19
N212489-002	8907099	2027-05-12		Drug substance	2020-05-19
N212489-002	8168793	2027-10-10	U-3869	Drug substance, Drug product	2020-05-19
N212489-002	9745290	2027-10-10	U-3869	Drug product	2020-05-19
N212489-002	8524746	2029-07-14	U-3869		2020-05-19
N212489-002	10071085	2030-03-31		Drug product	2020-05-19
N212489-002	10583130	2030-03-31	U-3869		2020-05-19
N212489-002	12129247	2032-01-11	U-4038		2024-11-26
N212489-002	9630955	2032-12-12	U-3869	Drug substance, Drug product	2020-05-19

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 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 22 · 844 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212489-001	9550759	2026-07-26	U-3870		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	9550759	2026-07-26	U-3871		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	9550759	2026-07-26	U-3872		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	8907099	2027-05-12		Drug substance	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	8168793	2027-10-10	U-3869	Drug substance, Drug product	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	9745290	2027-10-10	U-3869	Drug product	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	8524746	2029-07-14	U-3869		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	10071085	2030-03-31		Drug product	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	10583130	2030-03-31	U-3869		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	12129247	2032-01-11	U-4038		2024-11-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	9630955	2032-12-12	U-3869	Drug substance, Drug product	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	9550759	2026-07-26	U-3870		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	9550759	2026-07-26	U-3871		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	9550759	2026-07-26	U-3872		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	8907099	2027-05-12		Drug substance	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	8168793	2027-10-10	U-3869	Drug substance, Drug product	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	9745290	2027-10-10	U-3869	Drug product	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	8524746	2029-07-14	U-3869		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	10071085	2030-03-31		Drug product	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	10583130	2030-03-31	U-3869		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	12129247	2032-01-11	U-4038		2024-11-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	9630955	2032-12-12	U-3869	Drug substance, Drug product	2020-05-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212489-001	9550759	2026-07-26	U-3870		2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	9550759	2026-07-26	U-3871		2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	9550759	2026-07-26	U-3872		2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	8907099	2027-05-12		Drug substance	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	8168793	2027-10-10	U-3869	Drug substance, Drug product	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	9745290	2027-10-10	U-3869	Drug product	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	8524746	2029-07-14	U-3869		2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	10071085	2030-03-31		Drug product	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	10583130	2030-03-31	U-3869		2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	12129247	2032-01-11	U-4038		2024-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	9630955	2032-12-12	U-3869	Drug substance, Drug product	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-002	9550759	2026-07-26	U-3870		2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-002	9550759	2026-07-26	U-3871		2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-002	9550759	2026-07-26	U-3872		2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-002	8907099	2027-05-12		Drug substance	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-002	8168793	2027-10-10	U-3869	Drug substance, Drug product	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-002	9745290	2027-10-10	U-3869	Drug product	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-002	8524746	2029-07-14	U-3869		2020-05-19	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212489-001	NCE	2025-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212489-002	NCE	2025-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212489-001	NCE	2025-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212489-002	NCE	2025-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212489-001	NCE	2025-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212489-002	NCE	2025-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212489-001	NCE	2025-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212489-002	NCE	2025-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212489-001	NCE	2025-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212489-002	NCE	2025-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212489-001	NCE	2025-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212489-002	NCE	2025-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212489-001	NCE	2025-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212489-002	NCE	2025-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212489-001	NCE	2025-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212489-002	NCE	2025-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212489-001	NCE	2025-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212489-002	NCE	2025-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212489-001	NCE	2025-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212489-002	NCE	2025-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212489-001	NCE	2025-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212489-002	NCE	2025-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212489-001	NCE	2025-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212489-002	NCE	2025-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212489-001	NCE	2025-04-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212489-002	NCE	2025-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212489-001	NCE	2025-04-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212489-002	NCE	2025-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212489-001	NCE	2025-04-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212489-002	NCE	2025-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212489-001	NCE	2025-04-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212489-002	NCE	2025-04-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212489-001	NCE	2025-04-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212489-002	NCE	2025-04-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212489-001	NCE	2025-04-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212489-002	NCE	2025-04-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212489-001	NCE	2025-04-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212489-002	NCE	2025-04-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212489-001	NCE	2025-04-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N212489-002	NCE	2025-04-24	`5aa47cf7b7d7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70370-3025-2	EA - Each	70370-3025	b82add19-e5a3-4405-bd63-62f64622bbb0	1	2021-02-05

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
ONGENTYS	OPICAPONE	Amneal Pharmaceuticals LLC	a511a531-112e-43f8-a43f-5334b0efe979	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212489 application number: NDA212489

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Y5929UIJ5N	OPICAPONE	923287-50-7	OPICAPONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70370-3025-2	70370302502	30 CAPSULE in 1 BOTTLE (70370-3025-2)	30 capsule	2020-04-24	0000-00-00	No	No	Current