Home NDC 45865-829-60 ESZOPICLONE
Product NDC 45865-829
Requested package NDC 45865-829-60
11-digit product format 458650829
Labeler code 45865
Product ID 45865-829_9ab48833-f4f1-89fc-e053-2995a90a7d67
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ESZOPICLONE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Medsource Pharmaceuticals
Application ANDA091103
Marketing category ANDA
Marketing start 2014-04-15
Marketing end 0000-00-00
Substance ESZOPICLONE
Active strength 2 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 · 9 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 45865-829 45865-829-60 I Inactivated by FDA excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 45865-829 45865-829-60 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 45865-829 45865-829-60 I Inactivated by FDA excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 45865-829 45865-829-60 I Inactivated by FDA excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 45865-829 45865-829-60 I Inactivated by FDA excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 45865-829 45865-829-60 I Inactivated by FDA excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 45865-829 45865-829-60 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 45865-829 45865-829-60 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 45865-829 45865-829-60 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 A091103-001 ESZOPICLONE ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 A091103-002 ESZOPICLONE ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 A091103-003 ESZOPICLONE ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03
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 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ESZOPICLONE ESZOPICLONE Sun Pharmaceutical Industries, Inc. 8bb1965e-7845-4c5b-b021-38e251303d68 2018-10-25 Warnings, Adverse reactions Exact identifier application applno (ANDA): 091103 application number: ANDA091103
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 45865-829-20 ESZOPICLONE 20 in 1 BOTTLE TABLET, FILM COATED 20 3 45865-829-30 ESZOPICLONE 30 in 1 BOTTLE TABLET, FILM COATED 30 3 45865-829-60 ESZOPICLONE 60 in 1 BOTTLE TABLET, FILM COATED 60 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESZOPICLONE ACTIVE INGREDIENT UZX80K71OE ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 ESZOPICLONE ACTIVE MOIETY UZX80K71OE ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45865-829 ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 3 Legacy NDC, 3 package rows 20191228_1bbd525e-be06-310d-e054-00144ff88e88.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 45865-829-60 45865082960 60 TABLET, FILM COATED in 1 BOTTLE (45865-829-60) 2015-07-27 0000-00-00 No No Current