Eszopiclone

Product NDC: 50436-3384
Requested package NDC: 50436-3384-1
11-digit product format: 504363384
Labeler code: 50436
Product ID: 50436-3384_ef73dc24-4d37-473c-a242-6269bd7aceec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eszopiclone
Dosage form: TABLET, FILM COATED
Route: OROPHARYNGEAL
Labeler: Unit Dose Services
Application: ANDA091166
Marketing category: ANDA
Marketing start: 2014-04-15
Marketing end: 0000-00-00
Substance: ESZOPICLONE
Active strength: 3 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	50436-3384	50436-3384-1	I	Inactivated by FDA		2026-08-03

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
A091166-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15
A091166-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15
A091166-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091166-001	AB
A091166-002	AB
A091166-003	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	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`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	A091166-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091166-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091166-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091166-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091166-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091166-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091166-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091166-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091166-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091166-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091166-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091166-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091166-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091166-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091166-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091166-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091166-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091166-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091166-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091166-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091166-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091166-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091166-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091166-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091166-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091166-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091166-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091166-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091166-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091166-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091166-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091166-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091166-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091166-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091166-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091166-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091166-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091166-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091166-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091166-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eszopiclone	ESZOPICLONE	St Mary's Medical Park Pharmacy	c4ff1d6a-918e-c046-e053-2a95a90a9c9b	2026-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	Bryant Ranch Prepack	e04d4f8b-c9a1-4dc9-aac4-2e6376cd9a0c	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	Preferred Pharmaceuticals Inc.	0102ea59-77b1-4e74-83ec-1d205563b55f	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	NuCare Pharmaceuticals,Inc.	c24ec179-f869-746f-e053-2995a90aa1ff	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	Asclemed USA, Inc.	838559f7-4b69-4831-bf50-ab37c6c24c2b	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	Glenmark Pharmaceuticals Inc. USA	584dc66c-063a-4552-a056-74b811e2bc80	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	Bryant Ranch Prepack	d1baa5ba-73ac-462b-a728-217d5992674a	2024-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	1baa56e5-34d5-c8a1-e063-6394a90ae6c7	2024-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	Proficient Rx LP	e32746a8-6440-4b0a-a445-4467cf0329d5	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	Proficient Rx LP	ac996f97-fd92-44f8-8bb5-478a81ffb33d	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	Proficient Rx LP	edc03482-b013-448a-8cd9-2a17bd6d15e9	2022-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166

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
50436-3384-1	2024-01-30	C162847	48780-1	1030e365-1e62-111a-e063-dadaa90a10e2	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
50436-3384-1	Eszopiclone	30 in 1 BOTTLE	TABLET, FILM COATED	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-3384-1	EA - Each	50436-3384	98163379-d6c2-4141-883f-a964fbf76f28	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-3384	ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES]	3	Legacy NDC, 1 package rows	20220111_dc8db885-e4ef-4d72-9808-c5b2af258659.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	dc8db885-e4ef-4d72-9808-c5b2af258659	3
485465	eszopiclone 3 MG Oral Tablet	PSN	dc8db885-e4ef-4d72-9808-c5b2af258659	3
485442	eszopiclone 2 MG Oral Tablet	SCD	dc8db885-e4ef-4d72-9808-c5b2af258659	3
485465	eszopiclone 3 MG Oral Tablet	SCD	dc8db885-e4ef-4d72-9808-c5b2af258659	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50436-3384-1	50436338401	30 TABLET, FILM COATED in 1 BOTTLE (50436-3384-1)	2021-11-01	0000-00-00	No	No	Current