Home NDC 63090-170-60 NUPLAZID
Product NDC 63090-170
Requested package NDC 63090-170-60
11-digit product format 630900170
Labeler code 63090
Product ID 63090-170_cadc5a16-0bba-4c3f-ae1e-5767bf87071e
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 2016-04-29
Marketing end 2022-04-30
Substance PIMAVANSERIN TARTRATE
Active strength 17 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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NUPLAZID PIMAVANSERIN TARTRATE EQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-04-29 N207318-002 NUPLAZID PIMAVANSERIN TARTRATE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-06-28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.
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# 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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63090-170-60 63090017060 60 TABLET, COATED in 1 BOTTLE, PLASTIC (63090-170-60) 2016-04-29 2022-04-30 No No Current