Home NDC 80425-0115 Eszopiclone
Product NDC 80425-0115
11-digit product format 804250115
Labeler code 80425
Product ID 80425-0115_2a99a80e-d069-27e6-e063-6294a90ae0fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eszopiclone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Application ANDA091124
Marketing category ANDA
Marketing start 2014-04-15
Substance ESZOPICLONE
Active strength 3 mg/1
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091124-001 ESZOPICLONE ESZOPICLONE 1MG TABLET / ORAL 2011-09-13 A091124-002 ESZOPICLONE ESZOPICLONE 2MG TABLET / ORAL 2011-09-13 A091124-003 ESZOPICLONE ESZOPICLONE 3MG TABLET / ORAL 2011-09-13
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A091124-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091124-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091124-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091124-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091124-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091124-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091124-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091124-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091124-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091124-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091124-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091124-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091124-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091124-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091124-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091124-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091124-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091124-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091124-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091124-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091124-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091124-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-09-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091124-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-09-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091124-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091124-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-09-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091124-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-09-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091124-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091124-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-09-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091124-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-09-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091124-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091124-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-09-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091124-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-09-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091124-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091124-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-09-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091124-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-09-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091124-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091124-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-09-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091124-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-09-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091124-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091124-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-09-13 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Eszopiclone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESZOPICLONE 3 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination UZX80K71OE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 485465 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80425-0115-1 Eszopiclone 30 in 1 BOTTLE TABLET, FILM COATED 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0115 ESZOPICLONE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] 6 Current NDC, Legacy NDC, 1 package rows 20250101_b4f272eb-02e3-415a-e053-2a95a90a428f.zip
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 1 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eszopiclone ESZOPICLONE PD-Rx Pharmaceuticals, Inc. 4832cfbf-a540-46af-bb7d-3ba8e6bc783e 2025-10-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091124 application number: ANDA091124 ESZOPICLONE ESZOPICLONE DIRECT RX a7bd3e3c-26e9-07e7-e053-2995a90a9ca5 2025-01-17 Boxed warning, Adverse reactions Exact identifier application applno (ANDA): 091124 application number: ANDA091124 Eszopiclone ESZOPICLONE Advanced Rx of Tennessee, LLC b39dc64d-adc9-742e-e053-2a95a90ad18b 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091124 application number: ANDA091124 Eszopiclone ESZOPICLONE Advanced Rx Pharmacy of Tennessee, LLC b4f272eb-02e3-415a-e053-2a95a90a428f 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091124 application number: ANDA091124 ndc (product): 80425-0115 Eszopiclone ESZOPICLONE Lupin Pharmaceuticals, Inc. 7068c455-691e-4c56-9857-b7b4e13f4784 2024-01-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091124 application number: ANDA091124
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 80425-0115-1 80425011501 30 TABLET, FILM COATED in 1 BOTTLE (80425-0115-1) 2014-04-15 0000-00-00 No No Current