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United States · US · US:55111-629_bf1433f5-bde8-8c67-9ff7-ec5d3ed26581
Eszopiclone
In shortageOrange BookUNIISPLATC N05CF04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Limited
CountryUS (United States)
ATC codeN05CF04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115511162901100 TABLET, COATED in 1 BOTTLE (55111-629-01)
- ndc115511162905500 TABLET, COATED in 1 BOTTLE (55111-629-05)
- ndc11551116293030 TABLET, COATED in 1 BOTTLE (55111-629-30)
Annotations
UNII (FDA Substance ID)
UZX80K71OE
ESZOPICLONE
RxCUI 461016
Orange Book
A091024
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": "55111-629_bf1433f5-bde8-8c67-9ff7-ec5d3ed26581",
"productndc": "55111-629",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "091024",
"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": "ANDA091024",
"marketing_category": "ANDA",
"nonproprietary_name": "Eszopiclone",
"start_marketing_date": "20140415",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code N05CF04.
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