Home NDC 63402-190 Lunesta
Product NDC 63402-190
11-digit product format 634020190
Labeler code 63402
Product ID 63402-190_4c2704d7-3027-4240-9073-3f0b24cf15b5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ESZOPICLONE
Dosage form TABLET, COATED
Route ORAL
Labeler Sunovion Pharmaceuticals Inc.
Application NDA021476
Marketing category NDA
Marketing start 2005-04-04
Marketing end 0000-00-00
Substance ESZOPICLONE
Active strength 1 mg/1
DEA schedule CIV
NDC exclude flag No
Listing certified through 2022-12-31
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 · 4 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 63402-190-30 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 63402-190-30 f5e01cc5f278…a2eaf40c39c3…
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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESZOPICLONE ACTIVE INGREDIENT UZX80K71OE LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.] 19 ESZOPICLONE ACTIVE MOIETY UZX80K71OE LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.] 19 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.] 19 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.] 19 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.] 19 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.] 19 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.] 19 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.] 19 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.] 19 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.] 19 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.] 19 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.] 19 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.] 19 ESZOPICLONE ACTIVE INGREDIENT UZX80K71OE LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 3 ESZOPICLONE ACTIVE MOIETY UZX80K71OE LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 3 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 3 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 3 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63402-190 LUNESTA (ESZOPICLONE) TABLET, COATED [SUMITOMO PHARMA AMERICA, INC.] 31 Legacy NDC 20231212_fd047b2b-05a6-4d99-95cb-955f14bf329f.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 Marketing start Marketing end Sample Exclude flag Status 63402-190-30 63402019030 30 TABLET, COATED in 1 BOTTLE (63402-190-30) 2008-05-27 0000-00-00 No No Current