Eszopiclone

Product NDC: 70518-2979
Requested package NDC: 70518-2979-0
11-digit product format: 705182979
Labeler code: 70518
Product ID: 70518-2979_d3d40a15-2e3b-50d5-e053-2a95a90a348e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eszopiclone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA091124
Marketing category: ANDA
Marketing start: 2020-12-29
Marketing end: 0000-00-00
Substance: ESZOPICLONE
Active strength: 3 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	70518-2979	70518-2979-0	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 · 12 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	70518-2979	70518-2979-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-2979	70518-2979-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-2979	70518-2979-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-2979	70518-2979-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-2979	70518-2979-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-2979	70518-2979-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-2979	70518-2979-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-2979	70518-2979-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-2979	70518-2979-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2979	70518-2979-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2979	70518-2979-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-2979	70518-2979-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`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	Approval date
A091124-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	2011-09-13
A091124-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	2011-09-13
A091124-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	2011-09-13

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	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 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	A091124-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091124-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091124-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091124-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091124-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091124-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091124-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091124-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091124-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091124-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091124-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091124-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091124-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091124-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091124-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091124-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091124-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091124-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091124-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091124-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091124-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091124-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091124-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091124-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091124-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091124-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091124-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091124-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091124-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091124-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091124-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091124-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091124-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091124-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091124-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091124-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091124-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091124-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091124-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091124-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eszopiclone	ESZOPICLONE	PD-Rx Pharmaceuticals, Inc.	4832cfbf-a540-46af-bb7d-3ba8e6bc783e	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091124 application number: ANDA091124
ESZOPICLONE	ESZOPICLONE	DIRECT RX	a7bd3e3c-26e9-07e7-e053-2995a90a9ca5	2025-01-17	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 091124 application number: ANDA091124
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	b39dc64d-adc9-742e-e053-2a95a90ad18b	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091124 application number: ANDA091124
Eszopiclone	ESZOPICLONE	Advanced Rx Pharmacy of Tennessee, LLC	b4f272eb-02e3-415a-e053-2a95a90a428f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091124 application number: ANDA091124
Eszopiclone	ESZOPICLONE	Lupin Pharmaceuticals, Inc.	7068c455-691e-4c56-9857-b7b4e13f4784	2024-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091124 application number: ANDA091124

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2979-0	2023-03-14	C162847	48780-1	f386c649-a268-0266-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
70518-2979-0	2023-01-30	C162847	48780-1	f386c649-a268-0266-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

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
70518-2979-0	70518297900	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2979-0)	2020-12-29	0000-00-00	No	No	Current