Home NDC 45865-828 ESZOPICLONE
Product NDC 45865-828
11-digit product format 458650828
Labeler code 45865
Product ID 45865-828_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 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 · 6 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 45865-828 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 45865-828 45865-828-30 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product 45865-828 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 45865-828 45865-828-30 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 45865-828 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 45865-828 45865-828-30 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# 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 · 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 45865-828-30 ESZOPICLONE 30 in 1 BOTTLE TABLET, FILM COATED 30 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 45865-828 ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 3 Legacy NDC, 1 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 45865-828-30 45865082830 30 TABLET, FILM COATED in 1 BOTTLE (45865-828-30) 2015-07-27 0000-00-00 No No Current