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United States · US · US:68788-7169_9dec8075-bac4-4953-b317-f88ae1005a0e
Eszopiclone
In shortageOrange BookUNIISPLATC N05CF04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN05CF04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11687887169110 TABLET, FILM COATED in 1 BOTTLE (68788-7169-1)
- ndc11687887169220 TABLET, FILM COATED in 1 BOTTLE (68788-7169-2)
- ndc11687887169330 TABLET, FILM COATED in 1 BOTTLE (68788-7169-3)
- ndc11687887169660 TABLET, FILM COATED in 1 BOTTLE (68788-7169-6)
- ndc11687887169990 TABLET, FILM COATED in 1 BOTTLE (68788-7169-9)
Annotations
UNII (FDA Substance ID)
UZX80K71OE
ESZOPICLONE
RxCUI 461016
Orange Book
A202929
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": "68788-7169_9dec8075-bac4-4953-b317-f88ae1005a0e",
"productndc": "68788-7169",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202929",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "001",
"approval_date": "Jan 30, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "002",
"approval_date": "Jan 30, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "3MG",
"product_no": "003",
"approval_date": "Jan 30, 2015"
}
],
"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": "ANDA202929",
"marketing_category": "ANDA",
"nonproprietary_name": "Eszopiclone",
"start_marketing_date": "20180611",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code N05CF04.
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