FDA.reportPublic FDA data

eszopiclone 2 MG Oral Tablet

RxCUI
485442
RxNorm name
eszopiclone 2 MG Oral Tablet
Display name
eszopiclone 2 MG Oral Tablet
Full name
eszopiclone 2 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:51

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 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EszopicloneESZOPICLONEREMEDYREPACK INC.9dfe774a-2c7a-4e10-bedd-cde64ad286762026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
EszopicloneESZOPICLONEREMEDYREPACK INC.52ab8ee9-a04d-4e27-b0f4-eb050f1447152026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
EszopicloneESZOPICLONESt Mary's Medical Park Pharmacyc4ff1d6a-918e-c046-e053-2a95a90a9c9b2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
EszopicloneESZOPICLONEPreferred Pharmaceuticals Inc.abe3a610-a25d-4b52-8537-c87e8ba3104a2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
EszopicloneESZOPICLONEAsclemed USA, Inc.838559f7-4b69-4831-bf50-ab37c6c24c2b2026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
ESZOPICLONEESZOPICLONEDIRECT RX486b760b-7fea-306b-e054-00144ff8d46c2026-03-05Warnings, Adverse reactionsExact identifier
rxcui: 485442
EszopicloneESZOPICLONEGlenmark Pharmaceuticals Inc. USA584dc66c-063a-4552-a056-74b811e2bc802026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
ESZOPICLONEESZOPICLONEREMEDYREPACK INC.7df922bc-5750-4259-906f-64f960c38d5f2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
ESZOPICLONEESZOPICLONEA-S Medication Solutions923cc646-f22a-4a26-88f7-a19fce0163212025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
EszopicloneESZOPICLONEBryant Ranch Prepackf6022b2f-9b43-40cc-91c7-c224b209efab2025-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
EszopicloneESZOPICLONECamber Pharmaceuticals, Inc.00fc3250-3e29-4a4b-ac0c-74910659337c2025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
EszopicloneESZOPICLONEAsclemed USA, Inc.10175591-c1b4-461a-830e-8df982d0d2bf2025-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
LunestaESZOPICLONEWaylis Therapeutics LLC3821f4b7-a3c8-4920-ba80-18aa96532c092025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
EszopicloneESZOPICLONEAdvanced Rx of Tennessee, LLCaf86fca8-571a-0cac-e053-2a95a90ae4022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
EszopicloneESZOPICLONEAdvanced Rx of Tennessee, LLCaf86ebdb-e47b-706a-e053-2995a90ad51c2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
EszopicloneESZOPICLONEAdvanced Rx of Tennessee, LLCaf86fca8-571e-0cac-e053-2a95a90ae4022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
EszopicloneESZOPICLONEDr. Reddy's Laboratories Limited0b363b90-93dc-1fc1-0501-d140dfc762c72024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
EszopicloneESZOPICLONEQuality Care Products LLC7832f554-2b82-4ef2-b1ef-266179f271d32024-12-17Warnings, Adverse reactionsExact identifier
rxcui: 485442
EszopicloneESZOPICLONEBryant Ranch Prepackd1baa5ba-73ac-462b-a728-217d5992674a2024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
EszopicloneESZOPICLONEBryant Ranch Prepack9a891ab1-675f-498e-a21e-05964307d2dd2024-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442

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 · 47 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
923cc646-f22a-4a26-88f7-a19fce016321eszopiclone 2 MG Oral Tablet [PSN] · eszopiclone 2 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
f6022b2f-9b43-40cc-91c7-c224b209efabeszopiclone 2 MG Oral Tablet [PSN] · eszopiclone 2 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: 200420250924
9dfe774a-2c7a-4e10-bedd-cde64ad28676eszopiclone 2 MG Oral Tablet [PSN] · eszopiclone 2 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: 200420250724
e32746a8-6440-4b0a-a445-4467cf0329d5eszopiclone 2 MG Oral Tablet [PSN] · eszopiclone 2 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: 200420240201
c4ff1d6a-918e-c046-e053-2a95a90a9c9beszopiclone 2 MG Oral Tablet [PSN] · eszopiclone 2 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: 200420210617
bad8fe65-73c1-4542-8050-720af889905aeszopiclone 2 MG Oral Tablet [PSN] · eszopiclone 2 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: 200420201201
8edd5f22-cbdb-4286-8b35-9d09d84dafd7eszopiclone 2 MG Oral Tablet [PSN] · eszopiclone 2 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: 200420170630