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United States · US · US:61874-170_db2154b0-f0c7-403c-95fd-794666e79e30

Vraylar

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAllergan, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

Orange Book
N204370
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": "ORAL",
  "spl_meta": {
    "4b5f7c65-aa2d-452a-b3db-bc85c06ff12f": {
      "match": "brand_token",
      "title": "VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED VRAYLAR (CARIPRAZINE) KIT [ALLERGAN, INC.]",
      "spl_version": "30",
      "published_date": "2025-12-31"
    }
  },
  "productid": "61874-170_db2154b0-f0c7-403c-95fd-794666e79e30",
  "productndc": "61874-170",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "204370",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.5MG BASE",
        "product_no": "001",
        "approval_date": "Sep 17, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 3MG BASE",
        "product_no": "002",
        "approval_date": "Sep 17, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 4.5MG BASE",
        "product_no": "003",
        "approval_date": "Sep 17, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 6MG BASE",
        "product_no": "004",
        "approval_date": "Sep 17, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.5MG BASE",
        "product_no": "005",
        "approval_date": "Dec 18, 2025"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.75MG BASE",
        "product_no": "006",
        "approval_date": "Dec 18, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Vraylar",
  "active_ingred_unit": null,
  "application_number": "NDA204370",
  "marketing_category": "NDA",
  "nonproprietary_name": "cariprazine",
  "start_marketing_date": "20150917",
  "active_numerator_strength": null
}

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