Home NDC 0054-0290 eszopiclone
Product NDC 0054-0290
11-digit product format 000540290
Labeler code 0054
Product ID 0054-0290_accae4df-75e1-4493-a2f8-58bf28a327d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eszopiclone
Dosage form TABLET
Route ORAL
Labeler West-Ward Pharmaceuticals Corp.
Application ANDA091153
Marketing category ANDA
Marketing start 2014-04-15
Marketing end 2020-08-23
Substance ESZOPICLONE
Active strength 1 mg/1
DEA schedule CIV
NDC exclude flag No
Listing certified through 0000-00-00
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 · 14 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 2025-03-10 12:48 UTC · source 2025-03-10 excluded product product 0054-0290 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0054-0290 0054-0290-13 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 0054-0290 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0054-0290 0054-0290-13 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product 0054-0290 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0054-0290 0054-0290-13 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0054-0290 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0054-0290 0054-0290-13 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product 0054-0290 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0054-0290 0054-0290-13 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 0054-0290 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0054-0290 0054-0290-13 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 0054-0290 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0054-0290 0054-0290-13 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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 A091153-001 ESZOPICLONE ESZOPICLONE 1MG TABLET / ORAL 2014-04-15 A091153-002 ESZOPICLONE ESZOPICLONE 2MG TABLET / ORAL 2014-04-15 A091153-003 ESZOPICLONE ESZOPICLONE 3MG TABLET / ORAL 2014-04-15
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 A091153-001 ESZOPICLONE 1MG TABLET / ORAL 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091153-002 ESZOPICLONE 2MG TABLET / ORAL 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091153-003 ESZOPICLONE 3MG TABLET / ORAL 2014-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091153-001 ESZOPICLONE 1MG TABLET / ORAL 2014-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091153-002 ESZOPICLONE 2MG TABLET / ORAL 2014-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091153-003 ESZOPICLONE 3MG TABLET / ORAL 2014-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091153-001 ESZOPICLONE 1MG TABLET / ORAL 2014-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091153-002 ESZOPICLONE 2MG TABLET / ORAL 2014-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091153-003 ESZOPICLONE 3MG TABLET / ORAL 2014-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091153-001 ESZOPICLONE 1MG TABLET / ORAL 2014-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091153-002 ESZOPICLONE 2MG TABLET / ORAL 2014-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091153-003 ESZOPICLONE 3MG TABLET / ORAL 2014-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091153-001 ESZOPICLONE 1MG TABLET / ORAL 2014-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091153-002 ESZOPICLONE 2MG TABLET / ORAL 2014-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091153-003 ESZOPICLONE 3MG TABLET / ORAL 2014-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091153-001 ESZOPICLONE 1MG TABLET / ORAL 2014-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091153-002 ESZOPICLONE 2MG TABLET / ORAL 2014-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091153-003 ESZOPICLONE 3MG TABLET / ORAL 2014-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091153-001 ESZOPICLONE 1MG TABLET / ORAL 2014-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091153-002 ESZOPICLONE 2MG TABLET / ORAL 2014-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091153-003 ESZOPICLONE 3MG TABLET / ORAL 2014-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091153-001 ESZOPICLONE 1MG TABLET / ORAL 2014-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091153-002 ESZOPICLONE 2MG TABLET / ORAL 2014-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091153-003 ESZOPICLONE 3MG TABLET / ORAL 2014-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091153-001 ESZOPICLONE 1MG TABLET / ORAL 2014-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091153-002 ESZOPICLONE 2MG TABLET / ORAL 2014-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091153-003 ESZOPICLONE 3MG TABLET / ORAL 2014-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091153-001 ESZOPICLONE 1MG TABLET / ORAL 2014-04-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091153-002 ESZOPICLONE 2MG TABLET / ORAL 2014-04-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091153-003 ESZOPICLONE 3MG TABLET / ORAL 2014-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091153-001 ESZOPICLONE 1MG TABLET / ORAL 2014-04-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091153-002 ESZOPICLONE 2MG TABLET / ORAL 2014-04-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091153-003 ESZOPICLONE 3MG TABLET / ORAL 2014-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091153-001 ESZOPICLONE 1MG TABLET / ORAL 2014-04-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091153-002 ESZOPICLONE 2MG TABLET / ORAL 2014-04-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091153-003 ESZOPICLONE 3MG TABLET / ORAL 2014-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091153-001 ESZOPICLONE 1MG TABLET / ORAL 2014-04-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091153-002 ESZOPICLONE 2MG TABLET / ORAL 2014-04-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091153-003 ESZOPICLONE 3MG TABLET / ORAL 2014-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091153-001 ESZOPICLONE 1MG TABLET / ORAL 2014-04-15 8072bd15b7f6…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESZOPICLONE ACTIVE INGREDIENT UZX80K71OE ESZOPICLONE TABLET [PROFICIENT RX LP] 3 ESZOPICLONE ACTIVE MOIETY UZX80K71OE ESZOPICLONE TABLET [PROFICIENT RX LP] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ESZOPICLONE TABLET [PROFICIENT RX LP] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESZOPICLONE TABLET [PROFICIENT RX LP] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESZOPICLONE TABLET [PROFICIENT RX LP] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ESZOPICLONE TABLET [PROFICIENT RX LP] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESZOPICLONE TABLET [PROFICIENT RX LP] 3 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE ESZOPICLONE TABLET [PROFICIENT RX LP] 3 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B ESZOPICLONE TABLET [PROFICIENT RX LP] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESZOPICLONE TABLET [PROFICIENT RX LP] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESZOPICLONE TABLET [PROFICIENT RX LP] 3 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 ESZOPICLONE TABLET [PROFICIENT RX LP] 3 ESZOPICLONE ACTIVE INGREDIENT UZX80K71OE ESZOPICLONE TABLET [ROXANE LABORATORIES, INC.] 2 ESZOPICLONE ACTIVE MOIETY UZX80K71OE ESZOPICLONE TABLET [ROXANE LABORATORIES, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ESZOPICLONE TABLET [ROXANE LABORATORIES, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESZOPICLONE TABLET [ROXANE LABORATORIES, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESZOPICLONE TABLET [ROXANE LABORATORIES, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ESZOPICLONE TABLET [ROXANE LABORATORIES, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESZOPICLONE TABLET [ROXANE LABORATORIES, INC.] 2 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE ESZOPICLONE TABLET [ROXANE LABORATORIES, INC.] 2 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B ESZOPICLONE TABLET [ROXANE LABORATORIES, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESZOPICLONE TABLET [ROXANE LABORATORIES, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESZOPICLONE TABLET [ROXANE LABORATORIES, INC.] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 ESZOPICLONE TABLET [ROXANE LABORATORIES, INC.] 2