QUVIVIQ
These highlights do not include all the information needed to use QUVIVIQ safely and effectively. See full prescribing information for QUVIVIQ. QUVIVIQ (daridorexant) tablets, for oral use, CIV Initial U.S. Approval: 2022
Approved
Approval ID
3a2d1503-b816-40c9-9fac-7e03c5a3bcef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 2023
Manufacturers
FDA
Idorsia Pharmaceuticals Ltd
DUNS: 480176487
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Daridorexant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80491-7825
Application NumberNDA214985
Product Classification
M
Marketing Category
C73594
G
Generic Name
Daridorexant
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (14)
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
daridorexantActive
Quantity: 25 mg in 1 1
Code: LMQ24G57E9
Classification: ACTIB
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
Povidone K30Inactive
Code: U725QWY32X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Daridorexant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80491-7850
Application NumberNDA214985
Product Classification
M
Marketing Category
C73594
G
Generic Name
Daridorexant
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (15)
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
daridorexantActive
Quantity: 50 mg in 1 1
Code: LMQ24G57E9
Classification: ACTIB
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
Povidone K30Inactive
Code: U725QWY32X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT