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United States · US · US:80725-010_4a1b20fc-a41d-41dd-a557-fa9333bb5c3b
Lunesta
In shortageOrange BookUNIISPLATC N05CF04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWaylis Therapeutics LLC
CountryUS (United States)
ATC codeN05CF04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11807250103030 TABLET, COATED in 1 BOTTLE (80725-010-30)
Annotations
UNII (FDA Substance ID)
UZX80K71OE
ESZOPICLONE
RxCUI 461016
Orange Book
N021476
ABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Eszopiclone Tablet
Raw payload (JSON)
{
"unii": {
"unii": "UZX80K71OE",
"rxcui": "461016",
"inchikey": "GBBSUAFBMRNDJC-INIZCTEOSA-N",
"display_name": "ESZOPICLONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3821f4b7-a3c8-4920-ba80-18aa96532c09": {
"match": "brand_token",
"title": "LUNESTA (ESZOPICLONE) TABLET, COATED [WAYLIS THERAPEUTICS LLC]",
"spl_version": "2",
"published_date": "2025-01-10"
}
},
"productid": "80725-010_4a1b20fc-a41d-41dd-a557-fa9333bb5c3b",
"productndc": "80725-010",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "021476",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "1MG",
"product_no": "001",
"approval_date": "Dec 15, 2004"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "2MG",
"product_no": "002",
"approval_date": "Dec 15, 2004"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "3MG",
"product_no": "003",
"approval_date": "Dec 15, 2004"
}
],
"appl_type": "N"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESZOPICLONE",
"shortage_reason": "Eszopiclone Tablet",
"shortage_status": "current",
"proprietary_name": "Lunesta",
"active_ingred_unit": "mg/1",
"application_number": "NDA021476",
"marketing_category": "NDA",
"nonproprietary_name": "ESZOPICLONE",
"start_marketing_date": "20230815",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code N05CF04.
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