Home NDC 68258-7049 Lunesta
Product NDC 68258-7049
11-digit product format 682587049
Labeler code 68258
Product ID 68258-7049_abf41383-30a2-43ec-b4d3-1c17836b8900
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ESZOPICLONE
Dosage form TABLET, COATED
Route ORAL
Labeler Dispensing Solutions, Inc.
Application NDA021476
Marketing category NDA
Marketing start 2005-04-04
Marketing end 0000-00-00
Substance ESZOPICLONE
Active strength 3 mg/1
DEA schedule CIV
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 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 68258-7049-3 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 68258-7049-3 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 68258-7049-3 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 68258-7049-3 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 68258-7049-3 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 68258-7049-3 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 68258-7049-3 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 68258-7049-3 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 68258-7049-3 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 68258-7049-3 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 68258-7049-3 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 68258-7049-3 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 68258-7049-3 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 68258-7049-3 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 68258-7049-3 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 68258-7049-3 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 68258-7049-3 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 68258-7049-3 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 68258-7049-3 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 68258-7049-3 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68258-7049-3 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 68258-7049-3 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 N021476-001 LUNESTA ESZOPICLONE 1MG TABLET / ORAL AB RLD 2004-12-15 N021476-002 LUNESTA ESZOPICLONE 2MG TABLET / ORAL AB RLD 2004-12-15 N021476-003 LUNESTA ESZOPICLONE 3MG TABLET / ORAL AB RLD, RS 2004-12-15
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 N021476-001 LUNESTA 1MG TABLET / ORAL AB RLD 2004-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021476-002 LUNESTA 2MG TABLET / ORAL AB RLD 2004-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021476-003 LUNESTA 3MG TABLET / ORAL AB RLD, RS 2004-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021476-001 LUNESTA 1MG TABLET / ORAL AB RLD 2004-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021476-002 LUNESTA 2MG TABLET / ORAL AB RLD 2004-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021476-003 LUNESTA 3MG TABLET / ORAL AB RLD, RS 2004-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021476-001 LUNESTA 1MG TABLET / ORAL AB RLD 2004-12-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021476-002 LUNESTA 2MG TABLET / ORAL AB RLD 2004-12-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021476-003 LUNESTA 3MG TABLET / ORAL AB RLD, RS 2004-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021476-001 LUNESTA 1MG TABLET / ORAL AB RLD 2004-12-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021476-002 LUNESTA 2MG TABLET / ORAL AB RLD 2004-12-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021476-003 LUNESTA 3MG TABLET / ORAL AB RLD, RS 2004-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021476-001 LUNESTA 1MG TABLET / ORAL AB RLD 2004-12-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021476-002 LUNESTA 2MG TABLET / ORAL AB RLD 2004-12-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021476-003 LUNESTA 3MG TABLET / ORAL AB RLD, RS 2004-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021476-001 LUNESTA 1MG TABLET / ORAL AB RLD 2004-12-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021476-002 LUNESTA 2MG TABLET / ORAL AB RLD 2004-12-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021476-003 LUNESTA 3MG TABLET / ORAL AB RLD, RS 2004-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021476-001 LUNESTA 1MG TABLET / ORAL AB RLD 2004-12-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021476-002 LUNESTA 2MG TABLET / ORAL AB RLD 2004-12-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021476-003 LUNESTA 3MG TABLET / ORAL AB RLD, RS 2004-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021476-001 LUNESTA 1MG TABLET / ORAL AB RLD 2004-12-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021476-002 LUNESTA 2MG TABLET / ORAL AB RLD 2004-12-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021476-003 LUNESTA 3MG TABLET / ORAL AB RLD, RS 2004-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021476-001 LUNESTA 1MG TABLET / ORAL AB RLD 2004-12-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021476-002 LUNESTA 2MG TABLET / ORAL AB RLD 2004-12-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021476-003 LUNESTA 3MG TABLET / ORAL AB RLD, RS 2004-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021476-001 LUNESTA 1MG TABLET / ORAL AB RLD 2004-12-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021476-002 LUNESTA 2MG TABLET / ORAL AB RLD 2004-12-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021476-003 LUNESTA 3MG TABLET / ORAL AB RLD, RS 2004-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021476-001 LUNESTA 1MG TABLET / ORAL AB RLD 2004-12-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021476-002 LUNESTA 2MG TABLET / ORAL AB RLD 2004-12-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021476-003 LUNESTA 3MG TABLET / ORAL AB RLD, RS 2004-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021476-001 LUNESTA 1MG TABLET / ORAL AB RLD 2004-12-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021476-002 LUNESTA 2MG TABLET / ORAL AB RLD 2004-12-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021476-003 LUNESTA 3MG TABLET / ORAL AB RLD, RS 2004-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021476-001 LUNESTA 1MG TABLET / ORAL AB RLD 2004-12-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021476-002 LUNESTA 2MG TABLET / ORAL AB RLD 2004-12-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021476-003 LUNESTA 3MG TABLET / ORAL AB RLD, RS 2004-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021476-001 LUNESTA 1MG TABLET / ORAL AB RLD 2004-12-15 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 68258-7049-3 Lunesta 30 in 1 BOTTLE TABLET, COATED 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESZOPICLONE ACTIVE INGREDIENT UZX80K71OE LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.] 1 ESZOPICLONE ACTIVE MOIETY UZX80K71OE LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.] 1 ANHYDROUS DIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT L11K75P92J LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68258-7049 LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.] 1 Legacy NDC, 1 package rows 20111013_20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lunesta ESZOPICLONE Waylis Therapeutics LLC 3821f4b7-a3c8-4920-ba80-18aa96532c09 2025-01-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021476 application number: NDA021476
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 68258-7049-3 68258704903 30 in 1 BOTTLE Historical