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United States · US · US:63090-100_eccfc06d-c43d-45d6-b172-414f8de9865a
NUPLAZID
Orange BookUNIISPLATC N05AX17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAcadia Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN05AX17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11630901003030 TABLET, COATED in 1 BOTTLE, PLASTIC (63090-100-30)
Annotations
UNII (FDA Substance ID)
NA83F1SJSR
PIMAVANSERIN TARTRATE
RxCUI 1791686
Orange Book
N207318
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "NA83F1SJSR",
"rxcui": "1791686",
"inchikey": "RGSULKHNAKTFIZ-CEAXSRTFSA-N",
"display_name": "PIMAVANSERIN TARTRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1e6bea44-57d6-4bac-9328-46e1ee59f83b": {
"match": "brand_token",
"title": "NUPLAZID (PIMAVANSERIN TARTRATE) CAPSULE NUPLAZID (PIMAVANSERIN TARTRATE) TABLET, COATED [ACADIA PHARMACEUTICALS INC.]",
"spl_version": "22",
"published_date": "2026-05-20"
}
},
"productid": "63090-100_eccfc06d-c43d-45d6-b172-414f8de9865a",
"productndc": "63090-100",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "207318",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Apr 29, 2016"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 10MG BASE",
"product_no": "002",
"approval_date": "Jun 28, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PIMAVANSERIN TARTRATE",
"proprietary_name": "NUPLAZID",
"active_ingred_unit": "mg/1",
"application_number": "NDA207318",
"marketing_category": "NDA",
"nonproprietary_name": "pimavanserin tartrate",
"start_marketing_date": "20180628",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05AX17.
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