Home NDC 53217-307 Eszopiclone
Product NDC 53217-307
11-digit product format 532170307
Labeler code 53217
Product ID 53217-307_4f0270d8-fdba-4379-893f-0dc9269273e4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eszopiclone
Dosage form TABLET, COATED
Route ORAL
Labeler Aidarex Pharmaceuticals LLC
Application ANDA091024
Marketing category ANDA
Marketing start 2014-04-15
Marketing end 0000-00-00
Substance ESZOPICLONE
Active strength 2 mg/1
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 132 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 2026-10-15 13:18:30 2026-09 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 4 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53217-307-30 Eszopiclone 30 in 1 BOTTLE TABLET, COATED 30 1 53217-307-60 Eszopiclone 60 in 1 BOTTLE TABLET, COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53217-307 ESZOPICLONE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC] 1 Legacy NDC, 2 package rows 20170630_8edd5f22-cbdb-4286-8b35-9d09d84dafd7.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 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 Status 53217-307-30 53217030730 30 in 1 BOTTLE Historical 53217-307-60 53217030760 60 in 1 BOTTLE Historical