FDA.reportPublic FDA data

eszopiclone 1 MG Oral Tablet

RxCUI
485440
RxNorm name
eszopiclone 1 MG Oral Tablet
Display name
eszopiclone 1 MG Oral Tablet
Full name
eszopiclone 1 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:54

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ESZOPICLONEESZOPICLONEPreferred Pharmaceuticals, Inc.45558f0a-83f1-49b9-ab18-f436c0be96772026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
EszopicloneESZOPICLONEPreferred Pharmaceuticals Inc.0102ea59-77b1-4e74-83ec-1d205563b55f2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
EszopicloneESZOPICLONEAsclemed USA, Inc.838559f7-4b69-4831-bf50-ab37c6c24c2b2026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
EszopicloneESZOPICLONEProficient Rx LPdd7e4bab-8e25-4788-89e4-6b391f9596fe2026-02-01Warnings, Adverse reactionsExact identifier
rxcui: 485440
EszopicloneESZOPICLONEGlenmark Pharmaceuticals Inc. USA584dc66c-063a-4552-a056-74b811e2bc802026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
ESZOPICLONEESZOPICLONEA-S Medication Solutionsbfa767ce-340b-4d3a-a9c7-0043b6d7ff6e2025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
EszopicloneESZOPICLONECamber Pharmaceuticals, Inc.00fc3250-3e29-4a4b-ac0c-74910659337c2025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
EszopicloneESZOPICLONEAsclemed USA, Inc.10175591-c1b4-461a-830e-8df982d0d2bf2025-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
EszopicloneESZOPICLONEPreferred Pharmaceuticals Inc.be25bb4e-d84f-4396-a78f-a668a207cf2d2025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
ESZOPICLONEESZOPICLONEDIRECT RXa7bd3e3c-26e9-07e7-e053-2995a90a9ca52025-01-17Boxed warning, Adverse reactionsExact identifier
rxcui: 485440
LunestaESZOPICLONEWaylis Therapeutics LLC3821f4b7-a3c8-4920-ba80-18aa96532c092025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
EszopicloneESZOPICLONEAdvanced Rx of Tennessee, LLCb39dc64d-adc9-742e-e053-2a95a90ad18b2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
EszopicloneESZOPICLONEAdvanced Rx Pharmacy of Tennessee, LLCc8ae09eb-4c9b-4560-e053-2995a90a02b12024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
EszopicloneESZOPICLONEDr. Reddy's Laboratories Limited0b363b90-93dc-1fc1-0501-d140dfc762c72024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
EszopicloneESZOPICLONEBryant Ranch Prepackd1baa5ba-73ac-462b-a728-217d5992674a2024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
EszopicloneESZOPICLONEBryant Ranch Prepack9a891ab1-675f-498e-a21e-05964307d2dd2024-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
EszopicloneESZOPICLONEAdvanced Rx of Tennessee, LLC1baa56e5-34d5-c8a1-e063-6394a90ae6c72024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
EszopicloneESZOPICLONELupin Pharmaceuticals, Inc.7068c455-691e-4c56-9857-b7b4e13f47842024-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
ESZOPICLONEESZOPICLONEBionpharma Inc.ec6ac172-509e-403a-aa0d-4c60010a00352023-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
ESZOPICLONEESZOPICLONEBryant Ranch Prepack39b96725-2a01-4d9f-a56d-af7491b3b6012023-11-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 2 of 2 · 44 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
bfa767ce-340b-4d3a-a9c7-0043b6d7ff6eeszopiclone 1 MG Oral Tablet [PSN] · eszopiclone 1 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use ESZOPICLONE TABLETS safely and effectively. See full prescribing information for ESZOPICLONE TABLETS. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 200420251105
be25bb4e-d84f-4396-a78f-a668a207cf2deszopiclone 1 MG Oral Tablet [PSN] · eszopiclone 1 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use ESZOPICLONE TABLETS safely and effectively. See full prescribing information for ESZOPICLONE TABLETS. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 200420250210
397a8650-84fa-43ef-9006-922a39bc0b1deszopiclone 1 MG Oral Tablet [PSN] · eszopiclone 1 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets . Eszopiclone Tablets, for oral use, CIV Initial U.S. Approval: 200420170302
d483bd4d-f6ff-4942-94cc-00ed9655c29eeszopiclone 1 MG Oral Tablet [PSN] · eszopiclone 1 MG Oral Tablet [SCD]21ESZOPICLONE20151112