Home NDC 71335-1794-3 ESZOPICLONE
Product NDC 71335-1794
Requested package NDC 71335-1794-3
11-digit product format 713351794
Labeler code 71335
Product ID 71335-1794_2fd7fa6e-bb39-410b-8676-91ff34c2ce1e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ESZOPICLONE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA091113
Marketing category ANDA
Marketing start 2014-09-25
Marketing end 0000-00-00
Substance ESZOPICLONE
Active strength 3 mg/1
DEA schedule CIV
NDC exclude flag No
Listing certified through 2023-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 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 A091113-001 ESZOPICLONE ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 A091113-002 ESZOPICLONE ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 A091113-003 ESZOPICLONE ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10
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 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 71335-1794-1 These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004 71335-1794-2 These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004 71335-1794-3 These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004 71335-1794-4 These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004 71335-1794-5 These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004 71335-1794-6 These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004 71335-1794-7 These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004 71335-1794-8 These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-1794-1 ESZOPICLONE 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 102 71335-1794-2 ESZOPICLONE 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 102 71335-1794-3 ESZOPICLONE 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 102 71335-1794-4 ESZOPICLONE 120 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 120 102 71335-1794-5 ESZOPICLONE 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 102 71335-1794-6 ESZOPICLONE 28 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 28 102 71335-1794-7 ESZOPICLONE 15 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 15 102 71335-1794-8 ESZOPICLONE 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1794 ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 102 Legacy NDC, 8 package rows 20220226_2fd7fa6e-bb39-410b-8676-91ff34c2ce1e.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 · 1 matching rows.
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 71335-1794-3 71335179403 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1794-3) 2022-02-14 0000-00-00 No No Current