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United States · US · US:71205-633_5381d4b2-e743-4ece-9fe3-e2be6eb85711
Eszopiclone
In shortageOrange BookUNIISPLATC N05CF04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN05CF04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11712056333030 TABLET, FILM COATED in 1 BOTTLE (71205-633-30)
- ndc11712056336060 TABLET, FILM COATED in 1 BOTTLE (71205-633-60)
- ndc11712056339090 TABLET, FILM COATED in 1 BOTTLE (71205-633-90)
Annotations
UNII (FDA Substance ID)
UZX80K71OE
ESZOPICLONE
RxCUI 461016
Orange Book
A091166
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": "OROPHARYNGEAL",
"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": "71205-633_5381d4b2-e743-4ece-9fe3-e2be6eb85711",
"productndc": "71205-633",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "091166",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "001",
"approval_date": "Apr 15, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "002",
"approval_date": "Apr 15, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "3MG",
"product_no": "003",
"approval_date": "Apr 15, 2014"
}
],
"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": "ANDA091166",
"marketing_category": "ANDA",
"nonproprietary_name": "Eszopiclone",
"start_marketing_date": "20140415",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code N05CF04.
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