ESZOPICLONE

Product NDC: 50090-4202
11-digit product format: 500904202
Labeler code: 50090
Product ID: 50090-4202_7bd27a9a-eb31-40ed-a066-6b414b6295e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESZOPICLONE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA208451
Marketing category: ANDA
Marketing start: 2016-09-15
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-4202		D	Discontinued by firm		2026-08-03
excluded package	package	50090-4202	50090-4202-0	D	Discontinued by firm		2026-08-03

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 · 18 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	50090-4202-0	`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	50090-4202-0	`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	50090-4202-0	`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	50090-4202-0	`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	50090-4202-0	`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	50090-4202-0	`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	50090-4202-0	`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	50090-4202-0	`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	50090-4202-0	`0efc9e666f02…`	`f202fb6c5f17…`

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	Approval date
A208451-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15
A208451-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15
A208451-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A208451-001	AB
A208451-002	AB
A208451-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`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	A208451-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208451-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208451-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208451-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208451-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208451-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208451-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208451-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208451-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208451-001	AB	1	`8072bd15b7f6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4202-0	2023-02-07	C162847	48780-1	f386c649-c70b-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use ESZOPICLONE TABLETS safely and effectively. See full prescribing information for ESZOPICLONE TABLETS. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004
50090-4202-0	2023-01-30	C162847	48780-1	f386c649-c70b-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use ESZOPICLONE TABLETS safely and effectively. See full prescribing information for ESZOPICLONE TABLETS. ESZOPICLONE tablets, for oral use, CIV 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
50090-4202-0	EA - Each	50090-4202	104e61e5-076d-42c6-bc15-4da9399901df	1	2022-01-06

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ESZOPICLONE	ESZOPICLONE	Preferred Pharmaceuticals, Inc.	45558f0a-83f1-49b9-ab18-f436c0be9677	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	REMEDYREPACK INC.	7df922bc-5750-4259-906f-64f960c38d5f	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	A-S Medication Solutions	57a8450c-59ee-4c96-bef4-308fa7b97d1e	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	A-S Medication Solutions	bfa767ce-340b-4d3a-a9c7-0043b6d7ff6e	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	A-S Medication Solutions	e261bf7f-1b89-4393-8c48-4e72fc29192f	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	A-S Medication Solutions	923cc646-f22a-4a26-88f7-a19fce016321	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	PD-Rx Pharmaceuticals, Inc.	bb972d36-4b2c-45ae-8504-3a16d352dd8b	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	af869866-0a11-1a05-e053-2a95a90acdb8	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	af86fca8-571e-0cac-e053-2a95a90ae402	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	39b96725-2a01-4d9f-a56d-af7491b3b601	2023-11-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	Proficient Rx LP	2f4fa6e8-be82-4fb5-9a11-9ba8f557c027	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	Proficient Rx LP	024f833e-c20c-46a2-971b-3f2a716b1678	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	Aurobindo Pharma Limited	f18cc76f-82aa-4ad7-b8ce-5737733ee104	2021-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	Proficient Rx LP	bad8fe65-73c1-4542-8050-720af889905a	2020-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4202-0	50090420200	30 TABLET, FILM COATED in 1 BOTTLE (50090-4202-0)	2019-03-19	0000-00-00	No	No	Current