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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

  • ndc11
    7206014207
    7 CAPSULE in 1 BOTTLE (72060-142-07)
  • ndc11
    7206014240
    30 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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