Home Applications 021476 Application 021476
Type NDA
Sponsor SUNOVION PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LUNESTA ESZOPICLONE TABLET;ORAL 1MG Yes No 002 LUNESTA ESZOPICLONE TABLET;ORAL 2MG Yes No 003 LUNESTA ESZOPICLONE TABLET;ORAL 3MG Yes Yes
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.
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
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 25 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 21695-225 Lunesta eszopiclone Rebel Distributors Corp NDA Current 21695-226 Lunesta eszopiclone Rebel Distributors Corp NDA Current 50436-0193 Lunesta ESZOPICLONE Unit Dose Services NDA Current 52959-852 Lunesta ESZOPICLONE H.J. Harkins Company, Inc. NDA Current 52959-919 Lunesta ESZOPICLONE H.J. Harkins Company, Inc. NDA Current 55289-014 Lunesta ESZOPICLONE PD-Rx Pharmaceuticals, Inc. NDA Current 55289-014 Lunesta ESZOPICLONE PD-Rx Pharmaceuticals, Inc. NDA Current 55289-014 Lunesta ESZOPICLONE PD-Rx Pharmaceuticals, Inc. NDA Current 55289-014 Lunesta ESZOPICLONE PD-Rx Pharmaceuticals, Inc. NDA Current 55289-014 Lunesta ESZOPICLONE PD-Rx Pharmaceuticals, Inc. NDA Current 63402-190 Lunesta ESZOPICLONE Sunovion Pharmaceuticals Inc. NDA Current 63402-190 Lunesta ESZOPICLONE Sunovion Pharmaceuticals Inc. NDA Current 63402-190 Lunesta ESZOPICLONE Sunovion Pharmaceuticals Inc. NDA Current 63402-190 Lunesta ESZOPICLONE Sunovion Pharmaceuticals Inc. NDA Current 63402-191 Lunesta ESZOPICLONE Sunovion Pharmaceuticals Inc. NDA Current 63402-191 Lunesta ESZOPICLONE Sunovion Pharmaceuticals Inc. NDA Current 63402-191 Lunesta ESZOPICLONE Sunovion Pharmaceuticals Inc. NDA Current 63402-191 Lunesta ESZOPICLONE Sunovion Pharmaceuticals Inc. NDA Current 63402-193 Lunesta ESZOPICLONE Sunovion Pharmaceuticals Inc. NDA Current 63402-193 Lunesta ESZOPICLONE Sunovion Pharmaceuticals Inc. NDA Current 63402-193 Lunesta ESZOPICLONE Sunovion Pharmaceuticals Inc. NDA Current 63402-193 Lunesta ESZOPICLONE Sunovion Pharmaceuticals Inc. NDA Current 63629-3142 Lunesta ESZOPICLONE Bryant Ranch Prepack NDA Current 68258-7048 Lunesta ESZOPICLONE Dispensing Solutions, Inc. NDA Current 68258-7049 Lunesta ESZOPICLONE Dispensing Solutions, Inc. NDA Current