Home NDC 63090-340 NUPLAZID
Product NDC 63090-340
11-digit product format 630900340
Labeler code 63090
Product ID 63090-340_2199d74b-37ed-408c-97af-ef036899216b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pimavanserin tartrate
Dosage form CAPSULE
Route ORAL
Labeler Acadia Pharmaceuticals Inc.
Application NDA210793
Marketing category NDA
Marketing start 2018-06-28
Substance PIMAVANSERIN TARTRATE
Active strength 34 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210793-001 NUPLAZID PIMAVANSERIN TARTRATE EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28
Orange Book patents# Current patent rows page 1 of 1 · 13 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210793-001 7659285 2026-08-24 U-1844 2018-07-25 N210793-001 7732615 2028-06-03 Drug substance, Drug product 2018-07-25 N210793-001 7732615*PED 2028-12-03 Pediatric extension N210793-001 7601740 2030-04-29 Drug substance, Drug product 2018-07-25 N210793-001 7601740*PED 2030-10-29 Pediatric extension N210793-001 10449185 2038-08-27 Drug product 2019-11-01 N210793-001 10646480 2038-08-27 Drug product 2020-05-15 N210793-001 10849891 2038-08-27 U-1974 Drug product 2020-12-11 N210793-001 11452721 2038-08-27 Drug product 2022-09-27 N210793-001 10449185*PED 2039-02-27 Pediatric extension N210793-001 10646480*PED 2039-02-27 Pediatric extension N210793-001 10849891*PED 2039-02-27 Pediatric extension N210793-001 11452721*PED 2039-02-27 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210793-001 M-14 2029-04-27 N210793-001 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 2 · 43 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 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL AB RLD, RS 2018-06-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL AB RLD, RS 2018-06-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL AB RLD, RS 2018-06-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL AB RLD, RS 2018-06-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL AB RLD, RS 2018-06-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210793-001 NUPLAZID EQ 34MG BASE CAPSULE / ORAL RLD, RS 2018-06-28 f41ea6bd6efb…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 14 · 537 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 N210793-001 7659285 2026-08-24 U-1844 2018-07-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210793-001 7732615 2028-06-03 Drug substance, Drug product 2018-07-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210793-001 7732615*PED 2028-12-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210793-001 7601740 2030-04-29 Drug substance, Drug product 2018-07-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210793-001 7601740*PED 2030-10-29 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210793-001 10449185 2038-08-27 Drug product 2019-11-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210793-001 10646480 2038-08-27 Drug product 2020-05-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210793-001 10849891 2038-08-27 U-1974 Drug product 2020-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210793-001 11452721 2038-08-27 Drug product 2022-09-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210793-001 10449185*PED 2039-02-27 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210793-001 10646480*PED 2039-02-27 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210793-001 10849891*PED 2039-02-27 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210793-001 11452721*PED 2039-02-27 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210793-001 7659285 2026-08-24 U-1844 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210793-001 7732615 2028-06-03 Drug substance, Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210793-001 7732615*PED 2028-12-03 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210793-001 7601740 2030-04-29 Drug substance, Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210793-001 7601740*PED 2030-10-29 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210793-001 10449185 2038-08-27 Drug product 2019-11-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210793-001 10646480 2038-08-27 Drug product 2020-05-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210793-001 10849891 2038-08-27 U-1974 Drug product 2020-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210793-001 11452721 2038-08-27 Drug product 2022-09-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210793-001 10449185*PED 2039-02-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210793-001 10646480*PED 2039-02-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210793-001 10849891*PED 2039-02-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210793-001 11452721*PED 2039-02-27 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210793-001 7659285 2026-08-24 U-1844 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210793-001 7732615 2028-06-03 Drug substance, Drug product 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210793-001 7601740 2030-04-29 Drug substance, Drug product 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210793-001 10449185 2038-08-27 Drug product 2019-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210793-001 10646480 2038-08-27 Drug product 2020-05-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210793-001 10849891 2038-08-27 U-1974 Drug product 2020-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210793-001 11452721 2038-08-27 Drug product 2022-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210793-001 7923564 2025-09-26 Drug substance, Drug product 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210793-001 7659285 2026-08-24 U-1844 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210793-001 7732615 2028-06-03 Drug substance, Drug product 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210793-001 7601740 2030-04-29 Drug substance, Drug product 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210793-001 10449185 2038-08-27 Drug product 2019-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210793-001 10646480 2038-08-27 Drug product 2020-05-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210793-001 10849891 2038-08-27 U-1974 Drug product 2020-12-11 31067a03dcf5…
Observed Orange Book exclusivity history# 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 34 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63090-340-30 NUPLAZID 30 in 1 BOTTLE, PLASTIC CAPSULE 30 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63090-340 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): 210793 application number: NDA210793 ndc (product): 63090-340
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63090-340-30 63090034030 30 CAPSULE in 1 BOTTLE, PLASTIC (63090-340-30) 30 capsule 2018-06-28 0000-00-00 No No Current