ONGENTYS

Product NDC: 64896-403
Requested package NDC: 64896-403-03
11-digit product format: 648960403
Labeler code: 64896
Product ID: 64896-403_e12f99dd-db02-4070-8910-dd37eadf121c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: opicapone
Dosage form: CAPSULE
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: NDA212489
Marketing category: NDA
Marketing start: 2024-04-05
Substance: OPICAPONE
Active strength: 50 mg/1
Pharmacologic classes: Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]
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 44.

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	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	8168793	2032-04-07	U-3869	Drug substance, Drug product	2020-05-19
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	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	8168793	2032-04-07	U-3869	Drug substance, Drug product	2020-05-19
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 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`c2088c7a36db…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 22 · 866 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N212489-001	9550759	2026-07-26	U-3870		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	9550759	2026-07-26	U-3871		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	9550759	2026-07-26	U-3872		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	8907099	2027-05-12		Drug substance	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	9745290	2027-10-10	U-3869	Drug product	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	8524746	2029-07-14	U-3869		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	10071085	2030-03-31		Drug product	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	10583130	2030-03-31	U-3869		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	12129247	2032-01-11	U-4038		2024-11-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	8168793	2032-04-07	U-3869	Drug substance, Drug product	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	9630955	2032-12-12	U-3869	Drug substance, Drug product	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	9550759	2026-07-26	U-3870		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	9550759	2026-07-26	U-3871		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	9550759	2026-07-26	U-3872		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	8907099	2027-05-12		Drug substance	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	9745290	2027-10-10	U-3869	Drug product	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	8524746	2029-07-14	U-3869		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	10071085	2030-03-31		Drug product	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	10583130	2030-03-31	U-3869		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	12129247	2032-01-11	U-4038		2024-11-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	8168793	2032-04-07	U-3869	Drug substance, Drug product	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	9630955	2032-12-12	U-3869	Drug substance, Drug product	2020-05-19	`c2088c7a36db…`
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…`

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.

Additional Listing Data#

Finished product: Yes
Brand name base: ONGENTYS
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OPICAPONE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Y5929UIJ5N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2362172	Internal RxNorm lookup
2362178	Internal RxNorm lookup
2362180	Internal RxNorm lookup
2362182	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a511a531-112e-43f8-a43f-5334b0efe979	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9d36dead-9c0b-487f-a781-72d27cc6f76b	Product name	1	20200820

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64896-403-01	ONGENTYS	30 in 1 BOTTLE	CAPSULE	30	9
64896-403-02	ONGENTYS	7 in 1 BOTTLE	CAPSULE	7	9
64896-403-03	ONGENTYS	30 in 1 BOTTLE	CAPSULE	30	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64896-403-01	EA - Each	64896-403	e9d53891-c4f0-4103-9ecf-a5e91bbab4ea	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64896-403	ONGENTYS (OPICAPONE) CAPSULE [AMNEAL PHARMACEUTICALS LLC]	8	Current NDC, 3 package rows	20250330_a511a531-112e-43f8-a43f-5334b0efe979.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2362178	Ongentys 25 MG Oral Capsule	PSN	a511a531-112e-43f8-a43f-5334b0efe979	9
2362182	Ongentys 50 MG Oral Capsule	PSN	a511a531-112e-43f8-a43f-5334b0efe979	9
2362172	opicapone 25 MG Oral Capsule	PSN	a511a531-112e-43f8-a43f-5334b0efe979	9
2362180	opicapone 50 MG Oral Capsule	PSN	a511a531-112e-43f8-a43f-5334b0efe979	9
2362178	opicapone 25 MG Oral Capsule [Ongentys]	SBD	a511a531-112e-43f8-a43f-5334b0efe979	9
2362182	opicapone 50 MG Oral Capsule [Ongentys]	SBD	a511a531-112e-43f8-a43f-5334b0efe979	9
2362172	opicapone 25 MG Oral Capsule	SCD	a511a531-112e-43f8-a43f-5334b0efe979	9
2362180	opicapone 50 MG Oral Capsule	SCD	a511a531-112e-43f8-a43f-5334b0efe979	9
2362178	Ongentys 25 MG Oral Capsule	SY	a511a531-112e-43f8-a43f-5334b0efe979	9
2362182	Ongentys 50 MG Oral Capsule	SY	a511a531-112e-43f8-a43f-5334b0efe979	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64896-403-03	64896040303	30 CAPSULE in 1 BOTTLE (64896-403-03)	30 capsule	2024-04-05	Yes	No	Current