FDA.reportPublic FDA data

NDC 80425-0168-01 - Eszopiclone

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0168
Requested NDC
80425-0168-01
Package NDCs from labels
80425-0168-2, 80425-0168-3, 80425-0168-1, 80425-0168-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Eszopiclone - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0168-1Eszopiclone30 in 1 BOTTLETABLET, FILM COATED307
80425-0168-2Eszopiclone60 in 1 BOTTLETABLET, FILM COATED607
80425-0168-3Eszopiclone90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0168ESZOPICLONE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_c8ae09eb-4c9b-4560-e053-2995a90a02b1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0168-1EA - Each80425-0168b51d59ea-3e6c-44b9-a464-b840240f98bb12023-06-06
80425-0168-2EA - Each80425-01688b4fba70-0cf7-42d9-88b0-ae4d5b110f5c12023-04-07
80425-0168-3EA - Each80425-01686f4105d9-6c2d-4562-ae8a-8a80673c2be212023-06-06

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 reactionsExact identifier
application number: ANDA202929
rxcui: 485442
unii: UZX80K71OE
EszopicloneESZOPICLONEREMEDYREPACK INC.52ab8ee9-a04d-4e27-b0f4-eb050f1447152026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
unii: UZX80K71OE
EszopicloneESZOPICLONESt Mary's Medical Park Pharmacyc4ff1d6a-918e-c046-e053-2a95a90a9c9b2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
unii: UZX80K71OE
EszopicloneESZOPICLONEBryant Ranch Prepacke04d4f8b-c9a1-4dc9-aac4-2e6376cd9a0c2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
unii: UZX80K71OE
EszopicloneESZOPICLONEPreferred Pharmaceuticals Inc.2b5b4fbb-9b86-46c6-9508-37d3d9806dec2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202929
rxcui: 485465
unii: UZX80K71OE
ESZOPICLONEESZOPICLONEPreferred Pharmaceuticals, Inc.45558f0a-83f1-49b9-ab18-f436c0be96772026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
unii: UZX80K71OE
EszopicloneESZOPICLONEREMEDYREPACK INC.61fd4655-060f-4393-a610-019d8b1270582026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202929
rxcui: 485465
unii: UZX80K71OE
EszopicloneESZOPICLONEPreferred Pharmaceuticals Inc.abe3a610-a25d-4b52-8537-c87e8ba3104a2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202929
rxcui: 485442
unii: UZX80K71OE
EszopicloneESZOPICLONEPreferred Pharmaceuticals Inc.0102ea59-77b1-4e74-83ec-1d205563b55f2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
unii: UZX80K71OE
EszopicloneESZOPICLONENuCare Pharmaceuticals,Inc.c24ec179-f869-746f-e053-2995a90aa1ff2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
unii: UZX80K71OE
EszopicloneESZOPICLONEAsclemed USA, Inc.838559f7-4b69-4831-bf50-ab37c6c24c2b2026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
rxcui: 485442
rxcui: 485440
unii: UZX80K71OE
ESZOPICLONEESZOPICLONEDIRECT RX486b760b-7fea-306b-e054-00144ff8d46c2026-03-05Warnings, Adverse reactionsExact identifier
application number: ANDA202929
rxcui: 485442
unii: UZX80K71OE
EszopicloneESZOPICLONEProficient Rx LPdd7e4bab-8e25-4788-89e4-6b391f9596fe2026-02-01Warnings, Adverse reactionsExact identifier
rxcui: 485440
unii: UZX80K71OE
EszopicloneESZOPICLONEGlenmark Pharmaceuticals Inc. USA584dc66c-063a-4552-a056-74b811e2bc802026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
rxcui: 485442
rxcui: 485440
unii: UZX80K71OE
ESZOPICLONEESZOPICLONEREMEDYREPACK INC.7df922bc-5750-4259-906f-64f960c38d5f2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
unii: UZX80K71OE
ESZOPICLONEESZOPICLONEA-S Medication Solutions57a8450c-59ee-4c96-bef4-308fa7b97d1e2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
unii: UZX80K71OE
ESZOPICLONEESZOPICLONEA-S Medication Solutionsbfa767ce-340b-4d3a-a9c7-0043b6d7ff6e2025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485440
unii: UZX80K71OE
ESZOPICLONEESZOPICLONEA-S Medication Solutionse261bf7f-1b89-4393-8c48-4e72fc29192f2025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
unii: UZX80K71OE
ESZOPICLONEESZOPICLONEA-S Medication Solutions923cc646-f22a-4a26-88f7-a19fce0163212025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
unii: UZX80K71OE
EszopicloneESZOPICLONEPD-Rx Pharmaceuticals, Inc.4832cfbf-a540-46af-bb7d-3ba8e6bc783e2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485465
unii: UZX80K71OE

Reported adverse events (FAERS/openFDA)#

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