Vraylar

Orange BookUNIISPLATC N05AX15

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAllergan, Inc.

CountryUS (United States)

ATC codeN05AX15

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6187425030
30 CAPSULE, GELATIN COATED in 1 BOTTLE (61874-250-30)

Annotations

UNII (FDA Substance ID)

F6RJL8B278

CARIPRAZINE

RxCUI 1667655

Orange Book

N204370

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "F6RJL8B278",
    "rxcui": "1667655",
    "inchikey": "KPWSJANDNDDRMB-QAQDUYKDSA-N",
    "display_name": "CARIPRAZINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "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": "61874-250_db2154b0-f0c7-403c-95fd-794666e79e30",
  "productndc": "61874-250",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "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": "CARIPRAZINE",
  "proprietary_name": "Vraylar",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA204370",
  "marketing_category": "NDA",
  "nonproprietary_name": "cariprazine",
  "start_marketing_date": "20251218",
  "active_numerator_strength": ".5"
}

Related drugs

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