Home NDC 80725-011 Lunesta
Product NDC 80725-011
11-digit product format 807250011
Labeler code 80725
Product ID 80725-011_4a1b20fc-a41d-41dd-a557-fa9333bb5c3b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ESZOPICLONE
Dosage form TABLET, COATED
Route ORAL
Labeler Waylis Therapeutics LLC
Application NDA021476
Marketing category NDA
Marketing start 2023-08-15
Substance ESZOPICLONE
Active strength 2 mg/1
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing 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.
Additional Listing Data#
Finished product Yes
Brand name base Lunesta
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESZOPICLONE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination UZX80K71OE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 485440 Internal RxNorm lookup 485442 Internal RxNorm lookup 485465 Internal RxNorm lookup 540407 Internal RxNorm lookup 540409 Internal RxNorm lookup 540411 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80725-011-30 Lunesta 30 in 1 BOTTLE TABLET, COATED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80725-011 LUNESTA (ESZOPICLONE) TABLET, COATED [WAYLIS THERAPEUTICS LLC] 2 Current NDC, 1 package rows 20250110_3821f4b7-a3c8-4920-ba80-18aa96532c09.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 ndc (product): 80725-011
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 80725-011-30 80725001130 30 TABLET, COATED in 1 BOTTLE (80725-011-30) 2023-08-15 No No Current