Home NDC 61919-514 ESZOPICLONE
Product NDC 61919-514
11-digit product format 619190514
Labeler code 61919
Product ID 61919-514_9c940e14-e15a-1bba-e053-2a95a90a5599
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ESZOPICLONE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler DIRECT RX
Application ANDA091113
Marketing category ANDA
Marketing start 2015-12-15
Marketing end 0000-00-00
Substance ESZOPICLONE
Active strength 3 mg/1
DEA schedule CIV
NDC exclude flag No
Listing certified through 2021-12-31
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 · 32 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61919-514-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61919-514-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61919-514-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61919-514-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61919-514-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61919-514-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61919-514-30 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61919-514-30 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61919-514-30 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 61919-514-30 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 61919-514-30 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 61919-514-30 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 61919-514-30 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 61919-514-30 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 61919-514-30 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 61919-514-30 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61919-514-30 ESZOPICLONE 30 in 1 BOTTLE TABLET, FILM COATED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-514 ESZOPICLONE TABLET, FILM COATED [DIRECT RX] 2 Legacy NDC, 1 package rows 20200131_2cedcc9d-ab83-3b5a-e054-00144ff8d46c.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 61919-514-30 61919051430 30 TABLET, FILM COATED in 1 BOTTLE (61919-514-30) 2015-12-15 0000-00-00 No No Current