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United States · US · US:47335-587_95e952a3-5a7d-4b4c-9ac8-b5256a4371c3
ESZOPICLONE
In shortageOrange BookUNIISPLATC N05CF04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeN05CF04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc114733558708100 TABLET, FILM COATED in 1 BOTTLE (47335-587-08)
- ndc1147335587181000 TABLET, FILM COATED in 1 BOTTLE (47335-587-18)
- ndc11473355878330 TABLET, FILM COATED in 1 BOTTLE (47335-587-83)
- ndc114733558788100 TABLET, FILM COATED in 1 BOTTLE (47335-587-88)
Annotations
UNII (FDA Substance ID)
UZX80K71OE
ESZOPICLONE
RxCUI 461016
Orange Book
A091103
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": "47335-587_95e952a3-5a7d-4b4c-9ac8-b5256a4371c3",
"productndc": "47335-587",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "091103",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "001",
"approval_date": "Apr 3, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "002",
"approval_date": "Apr 3, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "3MG",
"product_no": "003",
"approval_date": "Apr 3, 2013"
}
],
"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": "ANDA091103",
"marketing_category": "ANDA",
"nonproprietary_name": "ESZOPICLONE",
"start_marketing_date": "20140415",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code N05CF04.
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