Lunesta

Product NDC: 63629-3142
11-digit product format: 636293142
Labeler code: 63629
Product ID: 63629-3142_ca386c45-4609-4bff-9bab-bdf0b879a7e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESZOPICLONE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
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

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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-3142		D	Discontinued by firm	2026-10-16
excluded package	package	63629-3142	63629-3142-1	D	Discontinued by firm	2026-10-16
excluded package	package	63629-3142	63629-3142-2	D	Discontinued by firm	2026-10-16
excluded package	package	63629-3142	63629-3142-3	D	Discontinued by firm	2026-10-16
excluded package	package	63629-3142	63629-3142-4	D	Discontinued by firm	2026-10-16
excluded package	package	63629-3142	63629-3142-5	D	Discontinued by firm	2026-10-16

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 2 · 90 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	63629-3142-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3142-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3142-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3142-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3142-1	`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	63629-3142-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3142-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3142-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3142-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3142-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3142-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3142-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3142-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3142-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3142-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3142-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3142-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3142-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3142-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3142-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3142-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3142-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3142-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3142-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3142-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3142-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3142-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3142-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3142-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3142-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3142-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3142-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3142-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3142-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3142-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3142-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3142-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3142-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3142-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3142-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3142-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3142-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3142-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3142-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3142-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3142-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3142-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3142-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3142-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3142-1	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 132 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
2026-10-15 13:18:30	2026-09	N021476-001	LUNESTA	1MG	TABLET / ORAL	AB	RLD	2004-12-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021476-002	LUNESTA	2MG	TABLET / ORAL	AB	RLD	2004-12-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021476-003	LUNESTA	3MG	TABLET / ORAL	AB	RLD, RS	2004-12-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021476-001	LUNESTA	1MG	TABLET / ORAL	AB	RLD	2004-12-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021476-002	LUNESTA	2MG	TABLET / ORAL	AB	RLD	2004-12-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021476-003	LUNESTA	3MG	TABLET / ORAL	AB	RLD, RS	2004-12-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021476-001	LUNESTA	1MG	TABLET / ORAL	AB	RLD	2004-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021476-002	LUNESTA	2MG	TABLET / ORAL	AB	RLD	2004-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021476-003	LUNESTA	3MG	TABLET / ORAL	AB	RLD, RS	2004-12-15	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021476-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021476-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021476-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021476-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021476-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021476-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021476-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021476-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021476-003	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021476-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021476-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021476-003	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-3142-1	2021-08-17	LUNESTA
63629-3142-2	2021-08-17	LUNESTA
63629-3142-3	2021-08-17	LUNESTA
63629-3142-4	2021-08-17	LUNESTA
63629-3142-5	2021-08-17	LUNESTA
63629-3142-1	2019-11-27	LUNESTA
63629-3142-2	2019-11-27	LUNESTA
63629-3142-3	2019-11-27	LUNESTA
63629-3142-4	2019-11-27	LUNESTA
63629-3142-5	2019-11-27	LUNESTA

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-3142-1	EA - Each	63629-3142	5c79f946-cca4-4369-b944-83ff92f22a40	1	2012-07-24
63629-3142-2	EA - Each	63629-3142	d4d280c6-1f7e-4cba-abb3-e7a6d952f35a	1	2015-10-02
63629-3142-3	EA - Each	63629-3142	4df6865c-245b-463b-a88d-1c3b2550b438	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESZOPICLONE	ACTIVE INGREDIENT	UZX80K71OE	LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]	2
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]	2

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