FDA.reportPublic FDA data

QUVIVIQ

Product NDC
80491-7850
11-digit product format
804917850
Labeler code
80491
Product ID
80491-7850_10e24e38-5645-433d-a160-82f4ed5b6dfb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Daridorexant
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Idorsia Pharmaceuticals Ltd
Application
NDA214985
Marketing category
NDA
Marketing start
2022-04-07
Substance
DARIDOREXANT
Active strength
50 mg/1
Pharmacologic classes
Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
QUVIVIQ
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DARIDOREXANT50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLMQ24G57E9
Rxcui2591502, 2591508, 2599096, 2599098

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5685e41d-bdc3-4cb9-b85e-9be3c9d3d673Product name120220125
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80491-7850-1QUVIVIQ1 in 1 CARTONTABLET, FILM COATED113
80491-7850-1QUVIVIQ7 in 1 BLISTER PACKTABLET, FILM COATED713
80491-7850-2QUVIVIQ1 in 1 CARTONTABLET, FILM COATED113
80491-7850-2QUVIVIQ7 in 1 BLISTER PACKTABLET, FILM COATED713
80491-7850-3QUVIVIQ1 in 1 CARTONTABLET, FILM COATED113
80491-7850-3QUVIVIQ30 in 1 BOTTLETABLET, FILM COATED3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80491-7850-3EA - Each80491-7850309e4529-b288-42b3-8fb2-19224a9ca51312022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80491-7850QUVIVIQ (DARIDOREXANT) TABLET, FILM COATED [IDORSIA PHARMACEUTICALS LTD]12Current NDC, Legacy NDC, 6 package rows20241013_3a2d1503-b816-40c9-9fac-7e03c5a3bcef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2591502daridorexant 25 MG Oral TabletPSN3a2d1503-b816-40c9-9fac-7e03c5a3bcef13
2599096daridorexant 50 MG Oral TabletPSN3a2d1503-b816-40c9-9fac-7e03c5a3bcef13
2591508QUVIVIQ 25 MG Oral TabletPSN3a2d1503-b816-40c9-9fac-7e03c5a3bcef13
2599098QUVIVIQ 50 MG Oral TabletPSN3a2d1503-b816-40c9-9fac-7e03c5a3bcef13
2591508daridorexant 25 MG Oral Tablet [Quviviq]SBD3a2d1503-b816-40c9-9fac-7e03c5a3bcef13
2599098daridorexant 50 MG Oral Tablet [Quviviq]SBD3a2d1503-b816-40c9-9fac-7e03c5a3bcef13
2591502daridorexant 25 MG Oral TabletSCD3a2d1503-b816-40c9-9fac-7e03c5a3bcef13
2599096daridorexant 50 MG Oral TabletSCD3a2d1503-b816-40c9-9fac-7e03c5a3bcef13
2591502daridorexant 25 MG (as daridorexant hydrochloride 27 MG) Oral TabletSY3a2d1503-b816-40c9-9fac-7e03c5a3bcef13
2599096daridorexant 50 MG (equivalent to daridorexant hydrochloride 54 MG) Oral TabletSY3a2d1503-b816-40c9-9fac-7e03c5a3bcef13
2591508Quviviq 25 MG (equivalent to daridorexant hydrochloride 27 MG) Oral TabletSY3a2d1503-b816-40c9-9fac-7e03c5a3bcef13
2599098Quviviq 50 MG (equivalent to daridorexant hydrochloride 54 MG) Oral TabletSY3a2d1503-b816-40c9-9fac-7e03c5a3bcef13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80491-7850-1804917850011 in 1 CARTONHistorical
80491-7850-2804917850021 BLISTER PACK in 1 CARTON (80491-7850-2) / 7 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2023-05-01YesNoHistorical
80491-7850-3804917850031 BOTTLE in 1 CARTON (80491-7850-3) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-04-070000-00-00NoNoCurrent