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United States · US · US:33342-301_66cfec66-191e-4af9-a623-8464417fab6d
Eszopiclone
In shortageOrange BookUNIISPLATC N05CF04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeN05CF04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc113334230111100 TABLET, FILM COATED in 1 BOTTLE (33342-301-11)
- ndc11333423011210 BLISTER PACK in 1 CARTON (33342-301-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1133342301441000 TABLET, FILM COATED in 1 BOTTLE (33342-301-44)
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": "33342-301_66cfec66-191e-4af9-a623-8464417fab6d",
"productndc": "33342-301",
"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": "20140425",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code N05CF04.
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