Home NDC 43353-185 Eszopiclone
Product NDC 43353-185
11-digit product format 433530185
Labeler code 43353
Product ID 43353-185_6b3fcf8b-dc69-41da-9e59-9cb9eaf03acd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eszopiclone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA091151
Marketing category ANDA
Marketing start 2016-01-19
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# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 18 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 43353-185 I Inactivated by FDA excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43353-185 43353-185-30 I Inactivated by FDA excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product 43353-185 I Inactivated by FDA excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43353-185 43353-185-30 I Inactivated by FDA excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 43353-185 I Inactivated by FDA excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43353-185 43353-185-30 I Inactivated by FDA excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product 43353-185 I Inactivated by FDA excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43353-185 43353-185-30 I Inactivated by FDA excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 43353-185 I Inactivated by FDA excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43353-185 43353-185-30 I Inactivated by FDA excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 43353-185 I Inactivated by FDA excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43353-185 43353-185-30 I Inactivated by FDA excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 43353-185 I Inactivated by FDA excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 43353-185 43353-185-30 I Inactivated by FDA excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 43353-185 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 43353-185 43353-185-30 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 43353-185 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 43353-185 43353-185-30 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 A091151-001 ESZOPICLONE ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 A091151-002 ESZOPICLONE ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 A091151-003 ESZOPICLONE ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26
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 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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 43353-185-30 Eszopiclone 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-185 ESZOPICLONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 4 Legacy NDC, 1 package rows 20191228_eb967d20-9a6d-4ccd-8618-22b87faa1d84.zip
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 43353-185-30 43353018530 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-185-30) 2016-06-10 0000-00-00 No No Current