Lunesta

Product NDC: 63402-191
Requested package NDC: 63402-191-10
11-digit product format: 634020191
Labeler code: 63402
Product ID: 63402-191_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: 2 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63402-191	63402-191-10	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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.

Application-product, TE code table
Application-product	TE code
N021476-001	AB
N021476-002	AB
N021476-003	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021476-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021476-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021476-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021476-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021476-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021476-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021476-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021476-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021476-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021476-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021476-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021476-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021476-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021476-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021476-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021476-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021476-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021476-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021476-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021476-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021476-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021476-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021476-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021476-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021476-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021476-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021476-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021476-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021476-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021476-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021476-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021476-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021476-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021476-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021476-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021476-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021476-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021476-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021476-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021476-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f65008ed-f925-2246-581a-e6a3201df7e4	Product name	5	20250107

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63402-191-03	2021-09-13	These highlights do not include all the information needed to use LUNESTA safely and effectively. See full prescribing information for LUNESTA. LUNESTA ® (eszopiclone) tablets, for oral use, C IV Initial U.S. Approval: 2004
63402-191-10	2021-09-13	These highlights do not include all the information needed to use LUNESTA safely and effectively. See full prescribing information for LUNESTA. LUNESTA ® (eszopiclone) tablets, for oral use, C IV Initial U.S. Approval: 2004
63402-191-30	2021-09-13	These highlights do not include all the information needed to use LUNESTA safely and effectively. See full prescribing information for LUNESTA. LUNESTA ® (eszopiclone) tablets, for oral use, C IV Initial U.S. Approval: 2004
63402-191-03	2021-07-23	These highlights do not include all the information needed to use LUNESTA safely and effectively. See full prescribing information for LUNESTA. LUNESTA ® (eszopiclone) tablets, for oral use, C IV Initial U.S. Approval: 2004
63402-191-10	2021-07-23	These highlights do not include all the information needed to use LUNESTA safely and effectively. See full prescribing information for LUNESTA. LUNESTA ® (eszopiclone) tablets, for oral use, C IV Initial U.S. Approval: 2004
63402-191-30	2021-07-23	These highlights do not include all the information needed to use LUNESTA safely and effectively. See full prescribing information for LUNESTA. LUNESTA ® (eszopiclone) tablets, for oral use, C IV Initial U.S. Approval: 2004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63402-191-03	EA - Each	63402-191	402a6ef7-dc74-4e54-a470-4ec9d89c3967	1	2018-12-13
63402-191-10	EA - Each	63402-191	9bb7d8e5-0992-4a38-954b-cd8acc6433f4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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 [H.J. HARKINS COMPANY, INC.]	3
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
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
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 [H.J. HARKINS COMPANY, 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 [H.J. HARKINS COMPANY, 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 [H.J. HARKINS COMPANY, 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 [H.J. HARKINS COMPANY, 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
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
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, 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
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, 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 [PHYSICIANS TOTAL CARE, INC.]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]	3
eszopiclone	ACTIVE INGREDIENT	UZX80K71OE	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
ESZOPICLONE	ACTIVE INGREDIENT	UZX80K71OE	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
eszopiclone	ACTIVE MOIETY	UZX80K71OE	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
Anhydrous Dibasic Calcium Phosphate	INACTIVE INGREDIENT	L11K75P92J	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	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 [REBEL DISTRIBUTORS CORP]	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 [REBEL DISTRIBUTORS CORP]	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 [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	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
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
triacetin	INACTIVE INGREDIENT	XHX3C3X673	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	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
63402-191	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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UZX80K71OE	ESZOPICLONE	138729-47-2	ESZOPICLONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485440	eszopiclone 1 MG Oral Tablet	PSN	5e5929f1-bdd9-4001-b542-b83de39540ec	3
485442	eszopiclone 2 MG Oral Tablet	PSN	1f468b3f-7edf-44aa-81e2-ddb1cc0c1724	3
485442	eszopiclone 2 MG Oral Tablet	PSN	5e5929f1-bdd9-4001-b542-b83de39540ec	3
485465	eszopiclone 3 MG Oral Tablet	PSN	1f468b3f-7edf-44aa-81e2-ddb1cc0c1724	3
485465	eszopiclone 3 MG Oral Tablet	PSN	5e5929f1-bdd9-4001-b542-b83de39540ec	3
540407	Lunesta 1 MG Oral Tablet	PSN	5e5929f1-bdd9-4001-b542-b83de39540ec	3
540409	Lunesta 2 MG Oral Tablet	PSN	5e5929f1-bdd9-4001-b542-b83de39540ec	3
540409	Lunesta 2 MG Oral Tablet	PSN	1f468b3f-7edf-44aa-81e2-ddb1cc0c1724	3
540411	Lunesta 3 MG Oral Tablet	PSN	5e5929f1-bdd9-4001-b542-b83de39540ec	3
540411	Lunesta 3 MG Oral Tablet	PSN	1f468b3f-7edf-44aa-81e2-ddb1cc0c1724	3
540407	eszopiclone 1 MG Oral Tablet [Lunesta]	SBD	5e5929f1-bdd9-4001-b542-b83de39540ec	3
540409	eszopiclone 2 MG Oral Tablet [Lunesta]	SBD	5e5929f1-bdd9-4001-b542-b83de39540ec	3
540409	eszopiclone 2 MG Oral Tablet [Lunesta]	SBD	1f468b3f-7edf-44aa-81e2-ddb1cc0c1724	3
540411	eszopiclone 3 MG Oral Tablet [Lunesta]	SBD	1f468b3f-7edf-44aa-81e2-ddb1cc0c1724	3
540411	eszopiclone 3 MG Oral Tablet [Lunesta]	SBD	5e5929f1-bdd9-4001-b542-b83de39540ec	3
485440	eszopiclone 1 MG Oral Tablet	SCD	5e5929f1-bdd9-4001-b542-b83de39540ec	3
485442	eszopiclone 2 MG Oral Tablet	SCD	5e5929f1-bdd9-4001-b542-b83de39540ec	3
485442	eszopiclone 2 MG Oral Tablet	SCD	1f468b3f-7edf-44aa-81e2-ddb1cc0c1724	3
485465	eszopiclone 3 MG Oral Tablet	SCD	1f468b3f-7edf-44aa-81e2-ddb1cc0c1724	3
485465	eszopiclone 3 MG Oral Tablet	SCD	5e5929f1-bdd9-4001-b542-b83de39540ec	3
540407	Lunesta 1 MG Oral Tablet	SY	5e5929f1-bdd9-4001-b542-b83de39540ec	3
540409	Lunesta 2 MG Oral Tablet	SY	1f468b3f-7edf-44aa-81e2-ddb1cc0c1724	3
540409	Lunesta 2 MG Oral Tablet	SY	5e5929f1-bdd9-4001-b542-b83de39540ec	3
540411	Lunesta 3 MG Oral Tablet	SY	5e5929f1-bdd9-4001-b542-b83de39540ec	3
540411	Lunesta 3 MG Oral Tablet	SY	1f468b3f-7edf-44aa-81e2-ddb1cc0c1724	3
485442	eszopiclone 2 MG Oral Tablet	PSN	7b069c49-007c-4f77-878c-0a6c564e2717	1
485442	eszopiclone 2 MG Oral Tablet	PSN	20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e	1
485465	eszopiclone 3 MG Oral Tablet	PSN	20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e	1
485465	eszopiclone 3 MG Oral Tablet	PSN	7b069c49-007c-4f77-878c-0a6c564e2717	1
540409	Lunesta 2 MG Oral Tablet	PSN	20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e	1
540409	Lunesta 2 MG Oral Tablet	PSN	7b069c49-007c-4f77-878c-0a6c564e2717	1
540411	Lunesta 3 MG Oral Tablet	PSN	20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e	1
540411	Lunesta 3 MG Oral Tablet	PSN	7b069c49-007c-4f77-878c-0a6c564e2717	1
540409	eszopiclone 2 MG Oral Tablet [Lunesta]	SBD	7b069c49-007c-4f77-878c-0a6c564e2717	1
540409	eszopiclone 2 MG Oral Tablet [Lunesta]	SBD	20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e	1
540411	eszopiclone 3 MG Oral Tablet [Lunesta]	SBD	20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e	1
540411	eszopiclone 3 MG Oral Tablet [Lunesta]	SBD	7b069c49-007c-4f77-878c-0a6c564e2717	1
485442	eszopiclone 2 MG Oral Tablet	SCD	7b069c49-007c-4f77-878c-0a6c564e2717	1
485442	eszopiclone 2 MG Oral Tablet	SCD	20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e	1
485465	eszopiclone 3 MG Oral Tablet	SCD	7b069c49-007c-4f77-878c-0a6c564e2717	1
485465	eszopiclone 3 MG Oral Tablet	SCD	20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e	1
540409	Lunesta 2 MG Oral Tablet	SY	7b069c49-007c-4f77-878c-0a6c564e2717	1
540409	Lunesta 2 MG Oral Tablet	SY	20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e	1
540411	Lunesta 3 MG Oral Tablet	SY	20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e	1
540411	Lunesta 3 MG Oral Tablet	SY	7b069c49-007c-4f77-878c-0a6c564e2717	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63402-191-10	63402019110	100 TABLET, COATED in 1 BOTTLE (63402-191-10)	2005-04-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lunesta	Sumitomo Pharma America, Inc.	2023-12-07	HUMAN PRESCRIPTION DRUG LABEL	31
LUNESTA ® (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg	Physicians Total Care, Inc.	2012-04-18	HUMAN PRESCRIPTION DRUG LABEL	3
LUNESTA ® (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg	H.J. Harkins Company, Inc.	2012-01-19	HUMAN PRESCRIPTION DRUG LABEL	3
LUNESTA ® (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg	Dispensing Solutions, Inc.	2011-10-10	HUMAN PRESCRIPTION DRUG LABEL	1
LUNESTA ® (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg	Rebel Distributors Corp	2010-10-01	HUMAN PRESCRIPTION DRUG LABEL	1