DAYVIGO
These highlights do not include all the information needed to use DAYVIGO safely and effectively. See full prescribing information for DAYVIGO . DAYVIGO (lemborexant) tablets, for oral use, CIV Initial U.S. Approval: 2019
Approved
Approval ID
7074cb65-77b3-45d2-8e8d-da8dc0f70bfd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
Eisai Inc.
DUNS: 189246791
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lemborexant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62856-405
Application NumberNDA212028
Product Classification
M
Marketing Category
C73594
G
Generic Name
lemborexant
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2024
FDA Product Classification
INGREDIENTS (11)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LEMBOREXANTActive
Quantity: 5 mg in 1 1
Code: 0K5743G68X
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (45000 WAMW)Inactive
Code: 8VAB711C5E
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)Inactive
Code: NZ94SDL6WR
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
lemborexant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62856-455
Application NumberNDA212028
Product Classification
M
Marketing Category
C73594
G
Generic Name
lemborexant
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2024
FDA Product Classification
INGREDIENTS (11)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEMBOREXANTActive
Quantity: 5 mg in 1 1
Code: 0K5743G68X
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (45000 WAMW)Inactive
Code: 8VAB711C5E
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)Inactive
Code: NZ94SDL6WR
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
lemborexant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62856-410
Application NumberNDA212028
Product Classification
M
Marketing Category
C73594
G
Generic Name
lemborexant
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2024
FDA Product Classification
INGREDIENTS (12)
LEMBOREXANTActive
Quantity: 10 mg in 1 1
Code: 0K5743G68X
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)Inactive
Code: NZ94SDL6WR
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (45000 WAMW)Inactive
Code: 8VAB711C5E
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT