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United States · US · US:65862-968_a39aa520-c8ad-4f39-ad71-04a839474b5b
ESZOPICLONE
In shortageOrange BookUNIISPLATC N05CF04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN05CF04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116586296801100 TABLET, FILM COATED in 1 BOTTLE (65862-968-01)
- ndc11658629683030 TABLET, FILM COATED in 1 BOTTLE (65862-968-30)
Annotations
UNII (FDA Substance ID)
UZX80K71OE
ESZOPICLONE
RxCUI 461016
Orange Book
A208451
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": {
"e04d4f8b-c9a1-4dc9-aac4-2e6376cd9a0c": {
"match": "brand_token",
"title": "ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]",
"spl_version": "102",
"published_date": "2026-05-25"
}
},
"productid": "65862-968_a39aa520-c8ad-4f39-ad71-04a839474b5b",
"productndc": "65862-968",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208451",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "001",
"approval_date": "Sep 15, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "002",
"approval_date": "Sep 15, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "3MG",
"product_no": "003",
"approval_date": "Sep 15, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESZOPICLONE",
"shortage_reason": "Eszopiclone Tablet",
"shortage_status": "current",
"proprietary_name": "ESZOPICLONE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208451",
"marketing_category": "ANDA",
"nonproprietary_name": "ESZOPICLONE",
"start_marketing_date": "20160915",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code N05CF04.
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