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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210793-001NUPLAZIDPIMAVANSERIN TARTRATEEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-28

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210793-00176592852026-08-24U-18442018-07-25
N210793-00177326152028-06-03Drug substance, Drug product2018-07-25
N210793-0017732615*PED2028-12-03Pediatric extension
N210793-00176017402030-04-29Drug substance, Drug product2018-07-25
N210793-0017601740*PED2030-10-29Pediatric extension
N210793-001104491852038-08-27Drug product2019-11-01
N210793-001106464802038-08-27Drug product2020-05-15
N210793-001108498912038-08-27U-1974Drug product2020-12-11
N210793-001114527212038-08-27Drug product2022-09-27
N210793-00110449185*PED2039-02-27Pediatric extension
N210793-00110646480*PED2039-02-27Pediatric extension
N210793-00110849891*PED2039-02-27Pediatric extension
N210793-00111452721*PED2039-02-27Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N210793-001M-142029-04-27
N210793-001PED2029-10-27

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-2884e616aacf4f…
2026-08-18 06:07:402026-07N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALABRLD, RS2018-06-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALABRLD, RS2018-06-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALABRLD, RS2018-06-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-283f01610625f2…
2019-09-15 20:21 UTC2019-09N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALABRLD, RS2018-06-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALABRLD, RS2018-06-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N210793-001NUPLAZIDEQ 34MG BASECAPSULE / ORALRLD, RS2018-06-28f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210793-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210793-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N210793-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N210793-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N210793-001AB11c564ffb4f44…

Observed Orange Book patent history#

Patent history page 1 of 14 · 537 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N210793-00176592852026-08-24U-18442018-07-2584e616aacf4f…
2026-09-14 22:38:342026-08N210793-00177326152028-06-03Drug substance, Drug product2018-07-2584e616aacf4f…
2026-09-14 22:38:342026-08N210793-0017732615*PED2028-12-03Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N210793-00176017402030-04-29Drug substance, Drug product2018-07-2584e616aacf4f…
2026-09-14 22:38:342026-08N210793-0017601740*PED2030-10-29Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N210793-001104491852038-08-27Drug product2019-11-0184e616aacf4f…
2026-09-14 22:38:342026-08N210793-001106464802038-08-27Drug product2020-05-1584e616aacf4f…
2026-09-14 22:38:342026-08N210793-001108498912038-08-27U-1974Drug product2020-12-1184e616aacf4f…
2026-09-14 22:38:342026-08N210793-001114527212038-08-27Drug product2022-09-2784e616aacf4f…
2026-09-14 22:38:342026-08N210793-00110449185*PED2039-02-27Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N210793-00110646480*PED2039-02-27Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N210793-00110849891*PED2039-02-27Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N210793-00111452721*PED2039-02-27Pediatric extension84e616aacf4f…
2026-08-18 06:07:402026-07N210793-00176592852026-08-24U-18442018-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07N210793-00177326152028-06-03Drug substance, Drug product2018-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07N210793-0017732615*PED2028-12-03Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N210793-00176017402030-04-29Drug substance, Drug product2018-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07N210793-0017601740*PED2030-10-29Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N210793-001104491852038-08-27Drug product2019-11-01caaa826d4ba7…
2026-08-18 06:07:402026-07N210793-001106464802038-08-27Drug product2020-05-15caaa826d4ba7…
2026-08-18 06:07:402026-07N210793-001108498912038-08-27U-1974Drug product2020-12-11caaa826d4ba7…
2026-08-18 06:07:402026-07N210793-001114527212038-08-27Drug product2022-09-27caaa826d4ba7…
2026-08-18 06:07:402026-07N210793-00110449185*PED2039-02-27Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N210793-00110646480*PED2039-02-27Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N210793-00110849891*PED2039-02-27Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N210793-00111452721*PED2039-02-27Pediatric extensioncaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210793-00176592852026-08-24U-18442018-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210793-00177326152028-06-03Drug substance, Drug product2018-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210793-00176017402030-04-29Drug substance, Drug product2018-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210793-001104491852038-08-27Drug product2019-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210793-001106464802038-08-27Drug product2020-05-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210793-001108498912038-08-27U-1974Drug product2020-12-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210793-001114527212038-08-27Drug product2022-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210793-00179235642025-09-26Drug substance, Drug product2018-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210793-00176592852026-08-24U-18442018-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210793-00177326152028-06-03Drug substance, Drug product2018-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210793-00176017402030-04-29Drug substance, Drug product2018-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210793-001104491852038-08-27Drug product2019-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210793-001106464802038-08-27Drug product2020-05-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210793-001108498912038-08-27U-1974Drug product2020-12-1131067a03dcf5…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N210793-001M-142029-04-2784e616aacf4f…
2026-09-14 22:38:342026-08N210793-001PED2029-10-2784e616aacf4f…
2026-08-18 06:07:402026-07N210793-001M-142029-04-27caaa826d4ba7…
2026-08-18 06:07:402026-07N210793-001PED2029-10-27caaa826d4ba7…
2019-12-13 00:20 UTC2019-12N210793-001NCE2021-04-2974a2ff9319b5…
2021-12-28 21:50 UTC2021-12N210793-001NCE2021-04-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N210793-001NCE2021-04-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N210793-001NCE2021-04-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N210793-001NCE2021-04-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N210793-001NCE2021-04-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N210793-001NCE2021-04-293f01610625f2…
2019-09-15 20:21 UTC2019-09N210793-001NCE2021-04-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N210793-001NCE2021-04-29ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N210793-001M-142029-04-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N210793-001PED2029-10-27a50c72e98297…

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
IngredientStrength
PIMAVANSERIN TARTRATE34 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NA83F1SJSRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2049269Internal RxNorm lookup
2049271Internal RxNorm lookup
2049275Internal RxNorm lookup
2049278Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e6bea44-57d6-4bac-9328-46e1ee59f83bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1d8bd08a-e111-4068-8539-c934574f1a15Product name220180815

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63090-340-30NUPLAZID30 in 1 BOTTLE, PLASTICCAPSULE3022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63090-340-30EA - Each63090-3407158556c-8e94-480b-9ae2-c1ba30cdd84412018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63090-340NUPLAZID (PIMAVANSERIN TARTRATE) CAPSULE NUPLAZID (PIMAVANSERIN TARTRATE) TABLET, COATED [ACADIA PHARMACEUTICALS INC.]21Current NDC, Legacy NDC, 1 package rows20250216_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUPLAZIDPIMAVANSERIN TARTRATEAcadia Pharmaceuticals Inc.1e6bea44-57d6-4bac-9328-46e1ee59f83b2026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 210793
application number: NDA210793
ndc (product): 63090-340

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2049271NUPLAZID 10 MG Oral TabletPSN1e6bea44-57d6-4bac-9328-46e1ee59f83b22
2049278NUPLAZID 34 MG Oral CapsulePSN1e6bea44-57d6-4bac-9328-46e1ee59f83b22
2049269pimavanserin 10 MG Oral TabletPSN1e6bea44-57d6-4bac-9328-46e1ee59f83b22
2049275pimavanserin 34 MG Oral CapsulePSN1e6bea44-57d6-4bac-9328-46e1ee59f83b22
2049271pimavanserin 10 MG Oral Tablet [Nuplazid]SBD1e6bea44-57d6-4bac-9328-46e1ee59f83b22
2049278pimavanserin 34 MG Oral Capsule [Nuplazid]SBD1e6bea44-57d6-4bac-9328-46e1ee59f83b22
2049269pimavanserin 10 MG Oral TabletSCD1e6bea44-57d6-4bac-9328-46e1ee59f83b22
2049275pimavanserin 34 MG Oral CapsuleSCD1e6bea44-57d6-4bac-9328-46e1ee59f83b22
2049271Nuplazid 10 MG Oral TabletSY1e6bea44-57d6-4bac-9328-46e1ee59f83b22
2049278Nuplazid 34 MG Oral CapsuleSY1e6bea44-57d6-4bac-9328-46e1ee59f83b22
2049269pimavanserin 10 mg (as pimavanserin tartrate 11.8 MG) Oral TabletSY1e6bea44-57d6-4bac-9328-46e1ee59f83b22
2049271pimavanserin 10 mg (as pimavanserin tartrate 11.8 MG) Oral Tablet [Nuplazid]SY1e6bea44-57d6-4bac-9328-46e1ee59f83b22
2049275pimavanserin 34 mg (as pimavanserin tartrate 40 MG) Oral CapsuleSY1e6bea44-57d6-4bac-9328-46e1ee59f83b22
2049278pimavanserin 34 mg (as pimavanserin tartrate 40 MG) Oral Capsule [Nuplazid]SY1e6bea44-57d6-4bac-9328-46e1ee59f83b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63090-340-306309003403030 CAPSULE in 1 BOTTLE, PLASTIC (63090-340-30) 30 capsule2018-06-280000-00-00NoNoCurrent