Home NDC 43353-097-30 Eszopiclone
Product NDC 43353-097
Requested package NDC 43353-097-30
11-digit product format 433530097
Labeler code 43353
Product ID 43353-097_fcdcacb3-f8a2-4cef-beb0-316dc7485002
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eszopiclone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA091169
Marketing category ANDA
Marketing start 2014-05-15
Marketing end 0000-00-00
Substance ESZOPICLONE
Active strength 3 mg/1
DEA schedule CIV
NDC exclude flag No
Listing certified through 2020-12-31
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 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43353-097 43353-097-30 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43353-097 43353-097-30 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 A091169-001 ESZOPICLONE ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 A091169-002 ESZOPICLONE ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 A091169-003 ESZOPICLONE ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23
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 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-097 ESZOPICLONE (ESZOPICLONE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC 20160617_f8321fa5-1ed7-4e48-bf54-4c86e3e868b3.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43353-097-30 43353009730 30 TABLET, FILM COATED in 1 BOTTLE (43353-097-30) 2015-08-30 0000-00-00 No No Current