dayvigo

Generic: lemborexant

Labeler: eisai inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name dayvigo
Generic Name lemborexant
Labeler eisai inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lemborexant 10 mg/1

Manufacturer
Eisai Inc.

Identifiers & Regulatory

Product NDC 62856-410
Product ID 62856-410_c82838dc-6934-4541-8a02-bd44ee5bb82a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212028
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2020-04-07

Pharmacologic Class

Established (EPC)
orexin receptor antagonist [epc]
Mechanism of Action
orexin receptor antagonists [moa] cytochrome p450 2b6 inducers [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62856410
Hyphenated Format 62856-410

Supplemental Identifiers

RxCUI
2272408 2272414 2288425 2288427
UPC
0362856410304 0362856405300 0362856410908 0362856405904
UNII
0K5743G68X
NUI
N0000191000 N0000190998 N0000187064

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dayvigo (source: ndc)
Generic Name lemborexant (source: ndc)
Application Number NDA212028 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (62856-410-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (62856-410-90)
source: ndc

Packages (2)

62856-410-30 30 TABLET, FILM COATED in 1 BOTTLE (62856-410-30) 62856-410-90 90 TABLET, FILM COATED in 1 BOTTLE (62856-410-90)

Ingredients (1)

lemborexant (10 mg/1)

Linked Drug Pages (1)

DAYVIGO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c82838dc-6934-4541-8a02-bd44ee5bb82a", "openfda": {"nui": ["N0000191000", "N0000190998", "N0000187064"], "upc": ["0362856410304", "0362856405300", "0362856410908", "0362856405904"], "unii": ["0K5743G68X"], "rxcui": ["2272408", "2272414", "2288425", "2288427"], "spl_set_id": ["7074cb65-77b3-45d2-8e8d-da8dc0f70bfd"], "pharm_class_epc": ["Orexin Receptor Antagonist [EPC]"], "pharm_class_moa": ["Orexin Receptor Antagonists [MoA]", "Cytochrome P450 2B6 Inducers [MoA]"], "manufacturer_name": ["Eisai Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62856-410-30)", "package_ndc": "62856-410-30", "marketing_start_date": "20200407"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62856-410-90)", "package_ndc": "62856-410-90", "marketing_start_date": "20200407"}], "brand_name": "DAYVIGO", "product_id": "62856-410_c82838dc-6934-4541-8a02-bd44ee5bb82a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2B6 Inducers [MoA]", "Orexin Receptor Antagonist [EPC]", "Orexin Receptor Antagonists [MoA]"], "product_ndc": "62856-410", "dea_schedule": "CIV", "generic_name": "lemborexant", "labeler_name": "Eisai Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DAYVIGO", "active_ingredients": [{"name": "LEMBOREXANT", "strength": "10 mg/1"}], "application_number": "NDA212028", "marketing_category": "NDA", "marketing_start_date": "20200407", "listing_expiration_date": "20261231"}