DAYVIGO

Product NDC
62856-455
11-digit product format
628560455
Labeler code
62856
Product ID
62856-455_c4274f49-6deb-4d9a-bd64-21728c025394
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lemborexant
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Eisai Inc.
Application
NDA212028
Marketing category
NDA
Marketing start
2020-04-07
Marketing end
0000-00-00
Substance
LEMBOREXANT
Active strength
5 mg/1
Pharmacologic classes
Cytochrome P450 2B6 Inducers [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3abc7c72-d84e-445a-b0eb-9dffce7056b8Product name120200605

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62856-455-10DAYVIGO1 in 1 CARTONTABLET, FILM COATED139
62856-455-10DAYVIGO5 in 1 TRAYTABLET, FILM COATED539

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62856-455DAYVIGO (LEMBOREXANT) TABLET, FILM COATED [EISAI INC.]39Legacy NDC, 2 package rows20250303_7074cb65-77b3-45d2-8e8d-da8dc0f70bfd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2288427DAYVIGO 10 MG Oral TabletPSN7074cb65-77b3-45d2-8e8d-da8dc0f70bfd39
2272414DAYVIGO 5 MG Oral TabletPSN7074cb65-77b3-45d2-8e8d-da8dc0f70bfd39
2288425lemborexant 10 MG Oral TabletPSN7074cb65-77b3-45d2-8e8d-da8dc0f70bfd39
2272408lemborexant 5 MG Oral TabletPSN7074cb65-77b3-45d2-8e8d-da8dc0f70bfd39
2288427lemborexant 10 MG Oral Tablet [Dayvigo]SBD7074cb65-77b3-45d2-8e8d-da8dc0f70bfd39
2272414lemborexant 5 MG Oral Tablet [Dayvigo]SBD7074cb65-77b3-45d2-8e8d-da8dc0f70bfd39
2288425lemborexant 10 MG Oral TabletSCD7074cb65-77b3-45d2-8e8d-da8dc0f70bfd39
2272408lemborexant 5 MG Oral TabletSCD7074cb65-77b3-45d2-8e8d-da8dc0f70bfd39
2288427Dayvigo 10 MG Oral TabletSY7074cb65-77b3-45d2-8e8d-da8dc0f70bfd39
2272414Dayvigo 5 MG Oral TabletSY7074cb65-77b3-45d2-8e8d-da8dc0f70bfd39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62856-455-10628560455105 CARTON in 1 TRAY (62856-455-10) > 1 BLISTER PACK in 1 CARTON > 10 TABLET, FILM COATED in 1 BLISTER PACK5 carton2020-04-070000-00-00YesNoCurrent