NUPLAZID

Product NDC: 63090-100
11-digit product format: 630900100
Labeler code: 63090
Product ID: 63090-100_2199d74b-37ed-408c-97af-ef036899216b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pimavanserin tartrate
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Acadia Pharmaceuticals Inc.
Application: NDA207318
Marketing category: NDA
Marketing start: 2018-06-28
Substance: PIMAVANSERIN TARTRATE
Active strength: 10 mg/1
Pharmacologic classes: Atypical Antipsychotic [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 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
N207318-001	NUPLAZID	PIMAVANSERIN TARTRATE	EQ 17MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-04-29
N207318-002	NUPLAZID	PIMAVANSERIN TARTRATE	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207318-001	7659285	2026-08-24	U-1844		2016-05-25
N207318-001	7732615	2028-06-03		Drug substance, Drug product	2016-05-25
N207318-001	7732615*PED	2028-12-03		Pediatric extension
N207318-001	7601740	2030-04-29		Drug substance, Drug product	2016-05-25
N207318-001	7601740*PED	2030-10-29		Pediatric extension
N207318-002	7659285	2026-08-24	U-1844		2018-07-25
N207318-002	7732615	2028-06-03		Drug substance, Drug product	2018-07-25
N207318-002	7732615*PED	2028-12-03		Pediatric extension
N207318-002	7601740	2030-04-29		Drug substance, Drug product	2018-07-25
N207318-002	7601740*PED	2030-10-29		Pediatric extension
N207318-002	10517860	2037-03-23	U-1974		2020-01-10
N207318-002	10953000	2037-03-23	U-1974		2021-03-30
N207318-002	10517860*PED	2037-09-23		Pediatric extension
N207318-002	10953000*PED	2037-09-23		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N207318-001	M-14	2029-04-27
N207318-001	PED	2029-10-27
N207318-002	M-14	2029-04-27
N207318-002	PED	2029-10-27

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 · 86 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
2026-09-14 22:38:34	2026-08	N207318-001	NUPLAZID	EQ 17MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207318-001	NUPLAZID	EQ 17MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207318-001	NUPLAZID	EQ 17MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207318-001	NUPLAZID	EQ 17MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207318-001	NUPLAZID	EQ 17MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207318-001	NUPLAZID	EQ 17MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207318-001	NUPLAZID	EQ 17MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207318-001	NUPLAZID	EQ 17MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207318-001	NUPLAZID	EQ 17MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207318-001	NUPLAZID	EQ 17MG BASE	TABLET / ORAL		RLD	2016-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207318-001	NUPLAZID	EQ 17MG BASE	TABLET / ORAL		RLD	2016-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207318-001	NUPLAZID	EQ 17MG BASE	TABLET / ORAL		RLD	2016-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207318-001	NUPLAZID	EQ 17MG BASE	TABLET / ORAL		RLD	2016-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207318-001	NUPLAZID	EQ 17MG BASE	TABLET / ORAL		RLD	2016-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	2018-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207318-001	NUPLAZID	EQ 17MG BASE	TABLET / ORAL		RLD	2016-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	2018-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207318-001	NUPLAZID	EQ 17MG BASE	TABLET / ORAL		RLD	2016-04-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	2018-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207318-001	NUPLAZID	EQ 17MG BASE	TABLET / ORAL		RLD	2016-04-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207318-001	NUPLAZID	EQ 17MG BASE	TABLET / ORAL		RLD	2016-04-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207318-001	NUPLAZID	EQ 17MG BASE	TABLET / ORAL		RLD	2016-04-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207318-001	NUPLAZID	EQ 17MG BASE	TABLET / ORAL		RLD	2016-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207318-002	NUPLAZID	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-06-28	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207318-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207318-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207318-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207318-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207318-002	AB	1	`1c564ffb4f44…`

Observed Orange Book patent history#

Patent history page 1 of 21 · 839 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	N207318-001	7659285	2026-08-24	U-1844		2016-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207318-001	7732615	2028-06-03		Drug substance, Drug product	2016-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207318-001	7732615*PED	2028-12-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207318-001	7601740	2030-04-29		Drug substance, Drug product	2016-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207318-001	7601740*PED	2030-10-29		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207318-002	7659285	2026-08-24	U-1844		2018-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207318-002	7732615	2028-06-03		Drug substance, Drug product	2018-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207318-002	7732615*PED	2028-12-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207318-002	7601740	2030-04-29		Drug substance, Drug product	2018-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207318-002	7601740*PED	2030-10-29		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207318-002	10517860	2037-03-23	U-1974		2020-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207318-002	10953000	2037-03-23	U-1974		2021-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207318-002	10517860*PED	2037-09-23		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207318-002	10953000*PED	2037-09-23		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207318-001	7659285	2026-08-24	U-1844		2016-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207318-001	7732615	2028-06-03		Drug substance, Drug product	2016-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207318-001	7732615*PED	2028-12-03		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207318-001	7601740	2030-04-29		Drug substance, Drug product	2016-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207318-001	7601740*PED	2030-10-29		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207318-002	7659285	2026-08-24	U-1844		2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207318-002	7732615	2028-06-03		Drug substance, Drug product	2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207318-002	7732615*PED	2028-12-03		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207318-002	7601740	2030-04-29		Drug substance, Drug product	2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207318-002	7601740*PED	2030-10-29		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207318-002	10517860	2037-03-23	U-1974		2020-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207318-002	10953000	2037-03-23	U-1974		2021-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207318-002	10517860*PED	2037-09-23		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207318-002	10953000*PED	2037-09-23		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207318-001	7659285	2026-08-24	U-1844		2016-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207318-001	7732615	2028-06-03		Drug substance, Drug product	2016-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207318-001	7601740	2030-04-29		Drug substance, Drug product	2016-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207318-002	7659285	2026-08-24	U-1844		2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207318-002	7732615	2028-06-03		Drug substance, Drug product	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207318-002	7601740	2030-04-29		Drug substance, Drug product	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207318-002	10517860	2037-03-23	U-1974		2020-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207318-002	10953000	2037-03-23	U-1974		2021-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207318-001	7923564	2025-09-26		Drug substance, Drug product	2016-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207318-001	7659285	2026-08-24	U-1844		2016-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207318-001	7732615	2028-06-03		Drug substance, Drug product	2016-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207318-001	7601740	2030-04-29		Drug substance, Drug product	2016-05-25	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N207318-001	M-14	2029-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207318-001	PED	2029-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207318-002	M-14	2029-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207318-002	PED	2029-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207318-001	M-14	2029-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207318-001	PED	2029-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207318-002	M-14	2029-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207318-002	PED	2029-10-27	`caaa826d4ba7…`
2019-12-13 00:20 UTC	2019-12	N207318-001	NCE	2021-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207318-002	NCE	2021-04-29	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N207318-001	NCE	2021-04-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207318-002	NCE	2021-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207318-001	NCE	2021-04-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207318-002	NCE	2021-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207318-001	NCE	2021-04-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N207318-002	NCE	2021-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207318-001	NCE	2021-04-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207318-002	NCE	2021-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207318-001	NCE	2021-04-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207318-002	NCE	2021-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207318-001	NCE	2021-04-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207318-002	NCE	2021-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207318-001	NCE	2021-04-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207318-002	NCE	2021-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207318-001	NCE	2021-04-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207318-002	NCE	2021-04-29	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N207318-001	M-14	2029-04-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N207318-001	PED	2029-10-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N207318-002	M-14	2029-04-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N207318-002	PED	2029-10-27	`a50c72e98297…`

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: NUPLAZID
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PIMAVANSERIN TARTRATE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NA83F1SJSR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2049269	Internal RxNorm lookup
2049271	Internal RxNorm lookup
2049275	Internal RxNorm lookup
2049278	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
1e6bea44-57d6-4bac-9328-46e1ee59f83b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1d8bd08a-e111-4068-8539-c934574f1a15	Product name	2	20180815

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-02-07	These highlights do not include all the information needed to use NUPLAZID safely and effectively. See full prescribing information for NUPLAZID. NUPLAZID ® (pimavanserin) capsules, for oral use NUPLAZID ® (pimavanserin) tablets, for oral use Initial U.S. Approval: 2016
2022-02-07	These highlights do not include all the information needed to use NUPLAZID safely and effectively. See full prescribing information for NUPLAZID. NUPLAZID ® (pimavanserin) capsules, for oral use NUPLAZID ® (pimavanserin) tablets, for oral use Initial U.S. Approval: 2016
2022-01-28	These highlights do not include all the information needed to use NUPLAZID safely and effectively. See full prescribing information for NUPLAZID. NUPLAZID ® (pimavanserin) capsules, for oral use NUPLAZID ® (pimavanserin) tablets, for oral use Initial U.S. Approval: 2016
2022-01-28	These highlights do not include all the information needed to use NUPLAZID safely and effectively. See full prescribing information for NUPLAZID. NUPLAZID ® (pimavanserin) capsules, for oral use NUPLAZID ® (pimavanserin) tablets, for oral use Initial U.S. Approval: 2016

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63090-100-30	NUPLAZID	30 in 1 BOTTLE, PLASTIC	TABLET, COATED	30		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63090-100-30	EA - Each	63090-100	a6aff2e6-0884-4a2a-ab43-36639569cf31	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63090-100	NUPLAZID (PIMAVANSERIN TARTRATE) CAPSULE NUPLAZID (PIMAVANSERIN TARTRATE) TABLET, COATED [ACADIA PHARMACEUTICALS INC.]	21	Current NDC, Legacy NDC, 1 package rows	20250216_1e6bea44-57d6-4bac-9328-46e1ee59f83b.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
NUPLAZID	PIMAVANSERIN TARTRATE	Acadia Pharmaceuticals Inc.	1e6bea44-57d6-4bac-9328-46e1ee59f83b	2026-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207318 application number: NDA207318 ndc (product): 63090-100

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NA83F1SJSR	PIMAVANSERIN TARTRATE	706782-28-7	PIMAVANSERIN TARTRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2049271	NUPLAZID 10 MG Oral Tablet	PSN	1e6bea44-57d6-4bac-9328-46e1ee59f83b	22
2049278	NUPLAZID 34 MG Oral Capsule	PSN	1e6bea44-57d6-4bac-9328-46e1ee59f83b	22
2049269	pimavanserin 10 MG Oral Tablet	PSN	1e6bea44-57d6-4bac-9328-46e1ee59f83b	22
2049275	pimavanserin 34 MG Oral Capsule	PSN	1e6bea44-57d6-4bac-9328-46e1ee59f83b	22
2049271	pimavanserin 10 MG Oral Tablet [Nuplazid]	SBD	1e6bea44-57d6-4bac-9328-46e1ee59f83b	22
2049278	pimavanserin 34 MG Oral Capsule [Nuplazid]	SBD	1e6bea44-57d6-4bac-9328-46e1ee59f83b	22
2049269	pimavanserin 10 MG Oral Tablet	SCD	1e6bea44-57d6-4bac-9328-46e1ee59f83b	22
2049275	pimavanserin 34 MG Oral Capsule	SCD	1e6bea44-57d6-4bac-9328-46e1ee59f83b	22
2049271	Nuplazid 10 MG Oral Tablet	SY	1e6bea44-57d6-4bac-9328-46e1ee59f83b	22
2049278	Nuplazid 34 MG Oral Capsule	SY	1e6bea44-57d6-4bac-9328-46e1ee59f83b	22
2049269	pimavanserin 10 mg (as pimavanserin tartrate 11.8 MG) Oral Tablet	SY	1e6bea44-57d6-4bac-9328-46e1ee59f83b	22
2049271	pimavanserin 10 mg (as pimavanserin tartrate 11.8 MG) Oral Tablet [Nuplazid]	SY	1e6bea44-57d6-4bac-9328-46e1ee59f83b	22
2049275	pimavanserin 34 mg (as pimavanserin tartrate 40 MG) Oral Capsule	SY	1e6bea44-57d6-4bac-9328-46e1ee59f83b	22
2049278	pimavanserin 34 mg (as pimavanserin tartrate 40 MG) Oral Capsule [Nuplazid]	SY	1e6bea44-57d6-4bac-9328-46e1ee59f83b	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63090-100-30	63090010030	30 TABLET, COATED in 1 BOTTLE, PLASTIC (63090-100-30)	2018-06-28	0000-00-00	No	No	Current