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United States · US · US:72060-142_fa0963da-0db0-41f8-bb1a-153908a8bd77
CAPLYTA
Orange BookUNIISPLATC N05AD10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIntra-Cellular Therapies, Inc
CountryUS (United States)
ATC codeN05AD10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1172060142077 CAPSULE in 1 BOTTLE (72060-142-07)
- ndc11720601424030 CAPSULE in 1 BOTTLE (72060-142-40)
Annotations
UNII (FDA Substance ID)
70BSQ12069
LUMATEPERONE
RxCUI 2275602
Orange Book
N209500
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "70BSQ12069",
"rxcui": "2275602",
"inchikey": "HOIIHACBCFLJET-SFTDATJTSA-N",
"display_name": "LUMATEPERONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"db730b06-6351-47fd-8183-e61e61bbead5": {
"match": "brand_token",
"title": "CAPLYTA (LUMATEPERONE) CAPSULE [INTRA-CELLULAR THERAPIES, INC]",
"spl_version": "27",
"published_date": "2026-06-01"
}
},
"productid": "72060-142_fa0963da-0db0-41f8-bb1a-153908a8bd77",
"productndc": "72060-142",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "209500",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 42MG BASE",
"product_no": "001",
"approval_date": "Dec 20, 2019"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 10.5MG BASE",
"product_no": "002",
"approval_date": "Apr 22, 2022"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 21MG BASE",
"product_no": "003",
"approval_date": "Apr 22, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LUMATEPERONE",
"proprietary_name": "CAPLYTA",
"active_ingred_unit": "mg/1",
"application_number": "NDA209500",
"marketing_category": "NDA",
"nonproprietary_name": "lumateperone",
"start_marketing_date": "20200201",
"active_numerator_strength": "42"
}Related drugs
Other records sharing ATC code N05AD10.
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