Home NDC 80425-0067 Eszopiclone
Product NDC 80425-0067
11-digit product format 804250067
Labeler code 80425
Product ID 80425-0067_2a98f01a-8da0-0770-e063-6294a90a7bab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eszopiclone
Dosage form TABLET, COATED
Route ORAL
Labeler Advanced Rx of Tennessee, LLC
Application ANDA091024
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 A091024-001 ESZOPICLONE ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 A091024-002 ESZOPICLONE ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 A091024-003 ESZOPICLONE ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 80425-0067-1 Eszopiclone 30 in 1 BOTTLE TABLET, COATED 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0067 ESZOPICLONE TABLET, COATED [ADVANCED RX OF TENNESSEE, LLC] 7 Current NDC, Legacy NDC, 1 package rows 20250101_af86b753-d2ee-9b5f-e053-2a95a90ad23d.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eszopiclone ESZOPICLONE Advanced Rx of Tennessee, LLC af86ebdb-e47b-706a-e053-2995a90ad51c 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091024 application number: ANDA091024 Eszopiclone ESZOPICLONE Advanced Rx of Tennessee, LLC af86b753-d2ee-9b5f-e053-2a95a90ad23d 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091024 application number: ANDA091024 ndc (product): 80425-0067 Eszopiclone ESZOPICLONE Dr. Reddy's Laboratories Limited 0b363b90-93dc-1fc1-0501-d140dfc762c7 2024-12-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091024 application number: ANDA091024
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 80425-0067-1 80425006701 30 TABLET, COATED in 1 BOTTLE (80425-0067-1) 2014-04-15 0000-00-00 No No Current