Home NDC 50436-0619 Eszopiclone
Product NDC 50436-0619
11-digit product format 504360619
Labeler code 50436
Product ID 50436-0619_0019dee9-0d88-4d70-89ab-c0980fb402e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eszopiclone
Dosage form TABLET, COATED
Route ORAL
Labeler Unit Dose Services
Application ANDA091024
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 · 38 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50436-0619-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50436-0619-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50436-0619-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50436-0619-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50436-0619-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50436-0619-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50436-0619-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50436-0619-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50436-0619-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50436-0619-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50436-0619-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50436-0619-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50436-0619-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50436-0619-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50436-0619-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 50436-0619-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 50436-0619-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 50436-0619-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 50436-0619-1 8dfbde2a14a4…c9ff85d89658…
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 A091024-001 ESZOPICLONE ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 A091024-002 ESZOPICLONE ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 A091024-003 ESZOPICLONE ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15
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 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50436-0619-1 Eszopiclone 30 in 1 BOTTLE TABLET, COATED 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50436-0619 ESZOPICLONE TABLET, COATED [UNIT DOSE SERVICES] 4 Legacy NDC, 1 package rows 20171108_6ed9115e-4cf1-4a1d-aaeb-d62cb1e0303f.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eszopiclone ESZOPICLONE Advanced Rx of Tennessee, LLC af86ebdb-e47b-706a-e053-2995a90ad51c 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091024 application number: ANDA091024 Eszopiclone ESZOPICLONE Advanced Rx of Tennessee, LLC af86b753-d2ee-9b5f-e053-2a95a90ad23d 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091024 application number: ANDA091024 Eszopiclone ESZOPICLONE Dr. Reddy's Laboratories Limited 0b363b90-93dc-1fc1-0501-d140dfc762c7 2024-12-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091024 application number: ANDA091024
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 50436-0619-1 50436061901 30 in 1 BOTTLE Historical