FDA.reportPublic FDA data

ESZOPICLONE - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2025-01-07
Label type
Indexing - Product Concept
Version
5
Source
full-release
Hydrated at
2026-06-05 00:24:41

Label at a glance#

ProductESZOPICLONE
Active ingredientESZOPICLONE

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ESZOPICLONEUZX80K71OEACTIB
ESZOPICLONEUZX80K71OEACTIB
ESZOPICLONEUZX80K71OEACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EszopicloneESZOPICLONEREMEDYREPACK INC.9dfe774a-2c7a-4e10-bedd-cde64ad286762026-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eszopiclone
generic name: ESZOPICLONE
EszopicloneESZOPICLONEREMEDYREPACK INC.52ab8ee9-a04d-4e27-b0f4-eb050f1447152026-09-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eszopiclone
generic name: ESZOPICLONE
EszopicloneESZOPICLONESt Mary's Medical Park Pharmacyc4ff1d6a-918e-c046-e053-2a95a90a9c9b2026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eszopiclone
generic name: ESZOPICLONE
EszopicloneESZOPICLONEBryant Ranch Prepacke04d4f8b-c9a1-4dc9-aac4-2e6376cd9a0c2026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eszopiclone
generic name: ESZOPICLONE
EszopicloneESZOPICLONEPreferred Pharmaceuticals Inc.2b5b4fbb-9b86-46c6-9508-37d3d9806dec2026-04-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eszopiclone
generic name: ESZOPICLONE
ESZOPICLONEESZOPICLONEPreferred Pharmaceuticals, Inc.45558f0a-83f1-49b9-ab18-f436c0be96772026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESZOPICLONE
generic name: ESZOPICLONE
EszopicloneESZOPICLONEREMEDYREPACK INC.61fd4655-060f-4393-a610-019d8b1270582026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eszopiclone
generic name: ESZOPICLONE
EszopicloneESZOPICLONEPreferred Pharmaceuticals Inc.abe3a610-a25d-4b52-8537-c87e8ba3104a2026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eszopiclone
generic name: ESZOPICLONE
EszopicloneESZOPICLONEPreferred Pharmaceuticals Inc.0102ea59-77b1-4e74-83ec-1d205563b55f2026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eszopiclone
generic name: ESZOPICLONE
EszopicloneESZOPICLONENuCare Pharmaceuticals,Inc.c24ec179-f869-746f-e053-2995a90aa1ff2026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eszopiclone
generic name: ESZOPICLONE
EszopicloneESZOPICLONEAsclemed USA, Inc.838559f7-4b69-4831-bf50-ab37c6c24c2b2026-03-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eszopiclone
generic name: ESZOPICLONE
ESZOPICLONEESZOPICLONEDIRECT RX486b760b-7fea-306b-e054-00144ff8d46c2026-03-05Warnings, Adverse reactionsName fallback
brand name: ESZOPICLONE
generic name: ESZOPICLONE
EszopicloneESZOPICLONEProficient Rx LPdd7e4bab-8e25-4788-89e4-6b391f9596fe2026-02-01Warnings, Adverse reactionsName fallback
brand name: Eszopiclone
generic name: ESZOPICLONE
EszopicloneESZOPICLONEGlenmark Pharmaceuticals Inc. USA584dc66c-063a-4552-a056-74b811e2bc802026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eszopiclone
generic name: ESZOPICLONE
ESZOPICLONEESZOPICLONEREMEDYREPACK INC.7df922bc-5750-4259-906f-64f960c38d5f2026-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESZOPICLONE
generic name: ESZOPICLONE
ESZOPICLONEESZOPICLONEA-S Medication Solutions57a8450c-59ee-4c96-bef4-308fa7b97d1e2025-11-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESZOPICLONE
generic name: ESZOPICLONE
ESZOPICLONEESZOPICLONEA-S Medication Solutionsbfa767ce-340b-4d3a-a9c7-0043b6d7ff6e2025-11-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESZOPICLONE
generic name: ESZOPICLONE
ESZOPICLONEESZOPICLONEA-S Medication Solutionse261bf7f-1b89-4393-8c48-4e72fc29192f2025-11-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESZOPICLONE
generic name: ESZOPICLONE
ESZOPICLONEESZOPICLONEA-S Medication Solutions923cc646-f22a-4a26-88f7-a19fce0163212025-11-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESZOPICLONE
generic name: ESZOPICLONE
EszopicloneESZOPICLONEPD-Rx Pharmaceuticals, Inc.4832cfbf-a540-46af-bb7d-3ba8e6bc783e2025-10-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eszopiclone
generic name: ESZOPICLONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.