FDA.reportPublic FDA data

eszopiclone 3 MG Oral Tablet

RxCUI
485465
RxNorm name
eszopiclone 3 MG Oral Tablet
Display name
eszopiclone 3 MG Oral Tablet
Full name
eszopiclone 3 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:24

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 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EszopicloneESZOPICLONEBryant Ranch Prepacke04d4f8b-c9a1-4dc9-aac4-2e6376cd9a0c2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
EszopicloneESZOPICLONEPreferred Pharmaceuticals Inc.2b5b4fbb-9b86-46c6-9508-37d3d9806dec2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
EszopicloneESZOPICLONEREMEDYREPACK INC.61fd4655-060f-4393-a610-019d8b1270582026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
EszopicloneESZOPICLONENuCare Pharmaceuticals,Inc.c24ec179-f869-746f-e053-2995a90aa1ff2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
EszopicloneESZOPICLONEAsclemed USA, Inc.838559f7-4b69-4831-bf50-ab37c6c24c2b2026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
EszopicloneESZOPICLONEGlenmark Pharmaceuticals Inc. USA584dc66c-063a-4552-a056-74b811e2bc802026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
ESZOPICLONEESZOPICLONEA-S Medication Solutions57a8450c-59ee-4c96-bef4-308fa7b97d1e2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
ESZOPICLONEESZOPICLONEA-S Medication Solutionse261bf7f-1b89-4393-8c48-4e72fc29192f2025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
EszopicloneESZOPICLONEPD-Rx Pharmaceuticals, Inc.4832cfbf-a540-46af-bb7d-3ba8e6bc783e2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
ESZOPICLONEESZOPICLONEPD-Rx Pharmaceuticals, Inc.bb972d36-4b2c-45ae-8504-3a16d352dd8b2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
EszopicloneESZOPICLONECamber Pharmaceuticals, Inc.00fc3250-3e29-4a4b-ac0c-74910659337c2025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
EszopicloneESZOPICLONEAsclemed USA, Inc.10175591-c1b4-461a-830e-8df982d0d2bf2025-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
LunestaESZOPICLONEWaylis Therapeutics LLC3821f4b7-a3c8-4920-ba80-18aa96532c092025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
EszopicloneESZOPICLONEAdvanced Rx of Tennessee, LLCaf863d89-25db-2893-e053-2a95a90a704c2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
EszopicloneESZOPICLONEAdvanced Rx of Tennessee, LLCaf869866-0a11-1a05-e053-2a95a90acdb82024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
EszopicloneESZOPICLONEAdvanced Rx of Tennessee, LLCaf86b753-d2ee-9b5f-e053-2a95a90ad23d2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
EszopicloneESZOPICLONEAdvanced Rx Pharmacy of Tennessee, LLCb4f272eb-02e3-415a-e053-2a95a90a428f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
EszopicloneESZOPICLONEDr. Reddy's Laboratories Limited0b363b90-93dc-1fc1-0501-d140dfc762c72024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
EszopicloneESZOPICLONEQuality Care Products LLC3b8a09c6-0702-43a7-b47f-a36cd00b75842024-12-17Warnings, Adverse reactionsExact identifier
rxcui: 485465
EszopicloneESZOPICLONEBryant Ranch Prepack9a891ab1-675f-498e-a21e-05964307d2dd2024-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465

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 · 50 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
c24ec179-f869-746f-e053-2995a90aa1ffeszopiclone 3 MG Oral Tablet [PSN] · eszopiclone 3 MG Oral Tablet [SCD]22These 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: 200420260313
838559f7-4b69-4831-bf50-ab37c6c24c2beszopiclone 3 MG Oral Tablet [PSN] · eszopiclone 3 MG Oral Tablet [SCD]22These 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: 200420260310
3821f4b7-a3c8-4920-ba80-18aa96532c09eszopiclone 3 MG Oral Tablet [PSN] · eszopiclone 3 MG Oral Tablet [SCD]22These highlights do not include all the information needed to use LUNESTA safely and effectively. See full prescribing information for LUNESTA. LUNESTA ® (eszopiclone) tablets, for oral use, C IV Initial U.S. Approval: 200420250108
673b7e99-1cbb-e888-e053-2a91aa0addc1eszopiclone 3 MG Oral Tablet [PSN] · eszopiclone 3 MG Oral Tablet [SCD]22ESZOPICLONE 3MG20200120
e261bf7f-1b89-4393-8c48-4e72fc29192feszopiclone 3 MG Oral Tablet [PSN] · eszopiclone 3 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
44815d96-2157-454f-8dbb-d0b47f439d6beszopiclone 3 MG Oral Tablet [PSN] · eszopiclone 3 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: 200420200803
9bbf260f-3090-46b5-b3ef-81174697f166eszopiclone 3 MG Oral Tablet [PSN] · eszopiclone 3 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: 200420200421
421c9fa7-107c-4265-9a7b-ac606b5c9923eszopiclone 3 MG Oral Tablet [PSN] · eszopiclone 3 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
20b122fb-42ec-4fa1-9a9e-e5930e5d2e7eeszopiclone 3 MG Oral Tablet [PSN] · eszopiclone 3 MG Oral Tablet [SCD]21LUNESTA ® (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg20111010
7b069c49-007c-4f77-878c-0a6c564e2717eszopiclone 3 MG Oral Tablet [PSN] · eszopiclone 3 MG Oral Tablet [SCD]21LUNESTA ® (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg20101001