Home NDC 52959-852 Lunesta
Product NDC 52959-852
11-digit product format 529590852
Labeler code 52959
Product ID 52959-852_feff9e75-95ba-4fb3-b286-c363cf4ea678
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ESZOPICLONE
Dosage form TABLET, COATED
Route ORAL
Labeler H.J. Harkins Company, 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 3 · 132 matching rows.
View current auxiliary records. · View the auxiliary file history.
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# NDC, Related label table NDC Related label 52959-852-00 LUNESTA ® (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg 52959-852-10 LUNESTA ® (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg 52959-852-12 LUNESTA ® (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg 52959-852-30 LUNESTA ® (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg 52959-852-60 LUNESTA ® (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52959-852-00 Lunesta 100 in 1 BOTTLE TABLET, COATED 100 3 52959-852-10 Lunesta 10 in 1 BOTTLE TABLET, COATED 10 3 52959-852-12 Lunesta 12 in 1 BOTTLE TABLET, COATED 12 3 52959-852-30 Lunesta 30 in 1 BOTTLE TABLET, COATED 30 3 52959-852-60 Lunesta 60 in 1 BOTTLE TABLET, COATED 60 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESZOPICLONE ACTIVE INGREDIENT UZX80K71OE LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] 3 ESZOPICLONE ACTIVE MOIETY UZX80K71OE LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] 3 ANHYDROUS DIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT L11K75P92J LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] 3 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] 3 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] 3 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-852 LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] 3 Legacy NDC, 5 package rows 20120120_1f468b3f-7edf-44aa-81e2-ddb1cc0c1724.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 52959-852-00 52959085200 100 in 1 BOTTLE Historical 52959-852-10 52959085210 10 in 1 BOTTLE Historical 52959-852-12 52959085212 12 in 1 BOTTLE Historical 52959-852-30 52959085230 30 in 1 BOTTLE Historical 52959-852-60 52959085260 60 in 1 BOTTLE Historical