QUVIVIQ

Orange BookUNIISPLATC N05CJ03

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

Identification

ManufacturerIdorsia Pharmaceuticals Ltd

CountryUS (United States)

ATC codeN05CJ03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
8049178502
1 BLISTER PACK in 1 CARTON (80491-7850-2) / 7 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
8049178503
1 BOTTLE in 1 CARTON (80491-7850-3) / 30 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

LMQ24G57E9

DARIDOREXANT

RxCUI 2591497

Orange Book

N214985

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "LMQ24G57E9",
    "rxcui": "2591497",
    "inchikey": "NBGABHGMJVIVBW-QHCPKHFHSA-N",
    "display_name": "DARIDOREXANT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3a2d1503-b816-40c9-9fac-7e03c5a3bcef": {
      "match": "brand_token",
      "title": "QUVIVIQ (DARIDOREXANT) TABLET, FILM COATED [IDORSIA PHARMACEUTICALS LTD]",
      "spl_version": "13",
      "published_date": "2026-03-02"
    }
  },
  "productid": "80491-7850_10e24e38-5645-433d-a160-82f4ed5b6dfb",
  "productndc": "80491-7850",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214985",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Apr 7, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Apr 7, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DARIDOREXANT",
  "proprietary_name": "QUVIVIQ",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214985",
  "marketing_category": "NDA",
  "nonproprietary_name": "Daridorexant",
  "start_marketing_date": "20220407",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code N05CJ03.

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