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United States · US · US:62856-405_c82838dc-6934-4541-8a02-bd44ee5bb82a
DAYVIGO
Orange BookUNIISPLATC N05CJ02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEisai Inc.
CountryUS (United States)
ATC codeN05CJ02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1162856405101 BLISTER PACK in 1 CARTON (62856-405-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11628564053030 TABLET, FILM COATED in 1 BOTTLE (62856-405-30)
- ndc11628564059090 TABLET, FILM COATED in 1 BOTTLE (62856-405-90)
Annotations
UNII (FDA Substance ID)
0K5743G68X
LEMBOREXANT
RxCUI 2272403
Orange Book
N212028
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0K5743G68X",
"rxcui": "2272403",
"inchikey": "MUGXRYIUWFITCP-PGRDOPGGSA-N",
"display_name": "LEMBOREXANT",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"7074cb65-77b3-45d2-8e8d-da8dc0f70bfd": {
"match": "brand_token",
"title": "DAYVIGO (LEMBOREXANT) TABLET, FILM COATED [EISAI INC.]",
"spl_version": "39",
"published_date": "2025-03-03"
}
},
"productid": "62856-405_c82838dc-6934-4541-8a02-bd44ee5bb82a",
"productndc": "62856-405",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "212028",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Apr 7, 2020"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Apr 7, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEMBOREXANT",
"proprietary_name": "DAYVIGO",
"active_ingred_unit": "mg/1",
"application_number": "NDA212028",
"marketing_category": "NDA",
"nonproprietary_name": "lemborexant",
"start_marketing_date": "20200407",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N05CJ02.
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