Eszopiclone

Product NDC: 70518-3576
11-digit product format: 705183576
Labeler code: 70518
Product ID: 70518-3576_4f5b4d7d-0b6c-54af-e063-6394a90a7c29
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eszopiclone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA202929
Marketing category: ANDA
Marketing start: 2022-11-10
Substance: ESZOPICLONE
Active strength: 3 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A202929-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30
A202929-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30
A202929-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202929-001	AB
A202929-002	AB
A202929-003	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	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`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	A202929-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202929-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202929-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202929-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202929-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202929-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202929-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202929-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202929-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202929-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202929-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202929-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202929-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202929-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202929-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202929-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202929-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202929-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202929-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202929-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202929-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202929-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202929-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202929-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202929-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202929-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202929-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202929-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202929-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202929-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202929-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202929-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202929-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202929-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202929-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202929-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202929-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202929-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202929-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202929-001	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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eszopiclone	ESZOPICLONE	Preferred Pharmaceuticals Inc.	2b5b4fbb-9b86-46c6-9508-37d3d9806dec	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	REMEDYREPACK INC.	61fd4655-060f-4393-a610-019d8b127058	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929 ndc (product): 70518-3576
Eszopiclone	ESZOPICLONE	Preferred Pharmaceuticals Inc.	abe3a610-a25d-4b52-8537-c87e8ba3104a	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
ESZOPICLONE	ESZOPICLONE	DIRECT RX	486b760b-7fea-306b-e054-00144ff8d46c	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Bryant Ranch Prepack	f6022b2f-9b43-40cc-91c7-c224b209efab	2025-09-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	REMEDYREPACK INC.	9dfe774a-2c7a-4e10-bedd-cde64ad28676	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Asclemed USA, Inc.	10175591-c1b4-461a-830e-8df982d0d2bf	2025-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Preferred Pharmaceuticals Inc.	be25bb4e-d84f-4396-a78f-a668a207cf2d	2025-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	af86fca8-571a-0cac-e053-2a95a90ae402	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	af863d89-25db-2893-e053-2a95a90a704c	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Advanced Rx Pharmacy of Tennessee, LLC	c8ae09eb-4c9b-4560-e053-2995a90a02b1	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Lake Erie Medical DBA Quality Care Products LLC	9460be93-cd53-4429-a4d9-2f04e3835168	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Quality Care Products LLC	3b8a09c6-0702-43a7-b47f-a36cd00b7584	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Quality Care Products LLC	7832f554-2b82-4ef2-b1ef-266179f271d3	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Bryant Ranch Prepack	9a891ab1-675f-498e-a21e-05964307d2dd	2024-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	NuCarePharmaceuticals, Inc.	53fcee89-027a-13e5-e054-00144ff8d46c	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Proficient Rx LP	d301b0cf-1492-4be9-83a0-1b64c8fa3b72	2023-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Macleods Pharmaceuticals Limited	12593790-e72f-45b1-8895-987cdd075134	2022-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Proficient Rx LP	5451be60-1315-4152-ad13-412e86903c8a	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Proficient Rx LP	1582ba77-a4e3-464f-876b-28cc7e41e8f1	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929

Additional Listing Data#

Finished product: Yes
Brand name base: Eszopiclone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESZOPICLONE	3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
UZX80K71OE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
485465	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
61fd4655-060f-4393-a610-019d8b127058	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f65008ed-f925-2246-581a-e6a3201df7e4	Product name	5	20250107

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-3576-0	Eszopiclone	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	5
70518-3576-1	Eszopiclone	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	5
70518-3576-2	Eszopiclone	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3576	ESZOPICLONE (ESZOPICLONE) TABLET, FILM COATED [REMEDYREPACK INC.]	2	Current NDC, Legacy NDC, 3 package rows	20240116_61fd4655-060f-4393-a610-019d8b127058.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
485465	eszopiclone 3 MG Oral Tablet	PSN	61fd4655-060f-4393-a610-019d8b127058	5
485465	eszopiclone 3 MG Oral Tablet	SCD	61fd4655-060f-4393-a610-019d8b127058	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3576-0	70518357600	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3576-0)	2022-11-10	0000-00-00	No	No	Current
70518-3576-1	70518357601	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3576-1)	2025-06-17		No	No	Current
70518-3576-2	70518357602	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3576-2)	2025-09-29		No	No	Current