Eszopiclone

Product NDC: 43353-185
Requested package NDC: 43353-185-30
11-digit product format: 433530185
Labeler code: 43353
Product ID: 43353-185_6b3fcf8b-dc69-41da-9e59-9cb9eaf03acd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: eszopiclone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA091151
Marketing category: ANDA
Marketing start: 2016-01-19
Marketing end: 0000-00-00
Substance: ESZOPICLONE
Active strength: 3 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2020-12-31
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	43353-185	43353-185-30	I	Inactivated by FDA		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 · 15 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-185	43353-185-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-185	43353-185-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-185	43353-185-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-185	43353-185-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-185	43353-185-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-185	43353-185-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-185	43353-185-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-185	43353-185-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-185	43353-185-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-185	43353-185-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-185	43353-185-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-185	43353-185-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-185	43353-185-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-185	43353-185-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-185	43353-185-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
A091151-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26
A091151-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26
A091151-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091151-001	AB
A091151-002	AB
A091151-003	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	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`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	A091151-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091151-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091151-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091151-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091151-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091151-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091151-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091151-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091151-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091151-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091151-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091151-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091151-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091151-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091151-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091151-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091151-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091151-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091151-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091151-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091151-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091151-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091151-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091151-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091151-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091151-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091151-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091151-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091151-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091151-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091151-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091151-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091151-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091151-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091151-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091151-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091151-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091151-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091151-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091151-001	AB	1	`8072bd15b7f6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eszopiclone	ESZOPICLONE	Golden State Medical Supply, Inc.	fef87d8d-f375-4b00-8765-957ef076bf1a	2023-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091151 application number: ANDA091151
Eszopiclone	ESZOPICLONE	Mylan Pharmaceuticals Inc.	5469cc59-78f9-447a-9c33-12553bb4073d	2022-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091151 application number: ANDA091151

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43353-185-30	2023-01-30	C162847	48780-1	f386c64a-1610-0266-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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-185-30	Eszopiclone	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-185-30	EA - Each	43353-185	fdb78b0e-bb54-443e-8f21-2fd4e136f921	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-185	ESZOPICLONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	4	Legacy NDC, 1 package rows	20191228_eb967d20-9a6d-4ccd-8618-22b87faa1d84.zip

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
485442	eszopiclone 2 MG Oral Tablet	PSN	eb967d20-9a6d-4ccd-8618-22b87faa1d84	4
485465	eszopiclone 3 MG Oral Tablet	PSN	eb967d20-9a6d-4ccd-8618-22b87faa1d84	4
485442	eszopiclone 2 MG Oral Tablet	SCD	eb967d20-9a6d-4ccd-8618-22b87faa1d84	4
485465	eszopiclone 3 MG Oral Tablet	SCD	eb967d20-9a6d-4ccd-8618-22b87faa1d84	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-185-30	43353018530	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-185-30)	2016-06-10	0000-00-00	No	No	Current