Eszopiclone

Product NDC: 33342-301
11-digit product format: 333420301
Labeler code: 33342
Product ID: 33342-301_66cfec66-191e-4af9-a623-8464417fab6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eszopiclone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Macleods Pharmaceuticals Limited
Application: ANDA202929
Marketing category: ANDA
Marketing start: 2014-04-25
Substance: ESZOPICLONE
Active strength: 3 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 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
2026-08-18 06:07:40	2026-07	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202929-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202929-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202929-003	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Eszopiclone
Listing expiration: 2026-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
485440	Internal RxNorm lookup
485442	Internal RxNorm lookup
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
12593790-e72f-45b1-8895-987cdd075134	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
33342-301-11	Eszopiclone	100 in 1 BOTTLE	TABLET, FILM COATED	100	9
33342-301-12	Eszopiclone	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	9
33342-301-12	Eszopiclone	10 in 1 CARTON	TABLET, FILM COATED	10	9
33342-301-44	Eszopiclone	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33342-301-11	EA - Each	33342-301	ecc8270b-a04e-440b-a928-d41233fd060e	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESZOPICLONE	ACTIVE INGREDIENT	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	3
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	3
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33342-301	ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	9	Current NDC, Legacy NDC, 4 package rows	20221102_12593790-e72f-45b1-8895-987cdd075134.zip

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 · 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
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 ndc (product): 33342-301
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

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
485440	eszopiclone 1 MG Oral Tablet	PSN	9a891ab1-675f-498e-a21e-05964307d2dd	21
485442	eszopiclone 2 MG Oral Tablet	PSN	9a891ab1-675f-498e-a21e-05964307d2dd	21
485465	eszopiclone 3 MG Oral Tablet	PSN	9a891ab1-675f-498e-a21e-05964307d2dd	21
485440	eszopiclone 1 MG Oral Tablet	SCD	9a891ab1-675f-498e-a21e-05964307d2dd	21
485442	eszopiclone 2 MG Oral Tablet	SCD	9a891ab1-675f-498e-a21e-05964307d2dd	21
485465	eszopiclone 3 MG Oral Tablet	SCD	9a891ab1-675f-498e-a21e-05964307d2dd	21
485440	eszopiclone 1 MG Oral Tablet	PSN	12593790-e72f-45b1-8895-987cdd075134	9
485442	eszopiclone 2 MG Oral Tablet	PSN	12593790-e72f-45b1-8895-987cdd075134	9
485465	eszopiclone 3 MG Oral Tablet	PSN	12593790-e72f-45b1-8895-987cdd075134	9
485465	eszopiclone 3 MG Oral Tablet	PSN	2b5b4fbb-9b86-46c6-9508-37d3d9806dec	9
485440	eszopiclone 1 MG Oral Tablet	SCD	12593790-e72f-45b1-8895-987cdd075134	9
485442	eszopiclone 2 MG Oral Tablet	SCD	12593790-e72f-45b1-8895-987cdd075134	9
485465	eszopiclone 3 MG Oral Tablet	SCD	12593790-e72f-45b1-8895-987cdd075134	9
485465	eszopiclone 3 MG Oral Tablet	SCD	2b5b4fbb-9b86-46c6-9508-37d3d9806dec	9
485440	eszopiclone 1 MG Oral Tablet	PSN	08a9069d-c914-48c8-a2cc-353965398f2c	7
485442	eszopiclone 2 MG Oral Tablet	PSN	08a9069d-c914-48c8-a2cc-353965398f2c	7
485465	eszopiclone 3 MG Oral Tablet	PSN	08a9069d-c914-48c8-a2cc-353965398f2c	7
485440	eszopiclone 1 MG Oral Tablet	SCD	08a9069d-c914-48c8-a2cc-353965398f2c	7
485442	eszopiclone 2 MG Oral Tablet	SCD	08a9069d-c914-48c8-a2cc-353965398f2c	7
485465	eszopiclone 3 MG Oral Tablet	SCD	08a9069d-c914-48c8-a2cc-353965398f2c	7
485465	eszopiclone 3 MG Oral Tablet	PSN	af863d89-25db-2893-e053-2a95a90a704c	6
485465	eszopiclone 3 MG Oral Tablet	PSN	3b8a09c6-0702-43a7-b47f-a36cd00b7584	6
485465	eszopiclone 3 MG Oral Tablet	SCD	af863d89-25db-2893-e053-2a95a90a704c	6
485465	eszopiclone 3 MG Oral Tablet	SCD	3b8a09c6-0702-43a7-b47f-a36cd00b7584	6
485465	eszopiclone 3 MG Oral Tablet	PSN	61fd4655-060f-4393-a610-019d8b127058	5
485465	eszopiclone 3 MG Oral Tablet	PSN	d301b0cf-1492-4be9-83a0-1b64c8fa3b72	5
485465	eszopiclone 3 MG Oral Tablet	SCD	61fd4655-060f-4393-a610-019d8b127058	5
485465	eszopiclone 3 MG Oral Tablet	SCD	d301b0cf-1492-4be9-83a0-1b64c8fa3b72	5
485465	eszopiclone 3 MG Oral Tablet	PSN	53fcee89-027a-13e5-e054-00144ff8d46c	4
485465	eszopiclone 3 MG Oral Tablet	SCD	53fcee89-027a-13e5-e054-00144ff8d46c	4
485465	eszopiclone 3 MG Oral Tablet	PSN	673c665b-488d-1d74-e053-2991aa0a543d	3
485465	eszopiclone 3 MG Oral Tablet	SCD	673c665b-488d-1d74-e053-2991aa0a543d	3
485440	eszopiclone 1 MG Oral Tablet	PSN	10175591-c1b4-461a-830e-8df982d0d2bf	2
485442	eszopiclone 2 MG Oral Tablet	PSN	10175591-c1b4-461a-830e-8df982d0d2bf	2
485465	eszopiclone 3 MG Oral Tablet	PSN	10175591-c1b4-461a-830e-8df982d0d2bf	2
485440	eszopiclone 1 MG Oral Tablet	SCD	10175591-c1b4-461a-830e-8df982d0d2bf	2
485442	eszopiclone 2 MG Oral Tablet	SCD	10175591-c1b4-461a-830e-8df982d0d2bf	2
485465	eszopiclone 3 MG Oral Tablet	SCD	10175591-c1b4-461a-830e-8df982d0d2bf	2
485465	eszopiclone 3 MG Oral Tablet	PSN	421c9fa7-107c-4265-9a7b-ac606b5c9923	1
485465	eszopiclone 3 MG Oral Tablet	SCD	421c9fa7-107c-4265-9a7b-ac606b5c9923	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
33342-301-11	33342030111	100 TABLET, FILM COATED in 1 BOTTLE (33342-301-11)		2015-01-31	0000-00-00	No	No	Current
33342-301-12	33342030112	10 BLISTER PACK in 1 CARTON (33342-301-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2015-01-31	0000-00-00	No	No	Current
33342-301-44	33342030144	1000 TABLET, FILM COATED in 1 BOTTLE (33342-301-44)		2015-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eszopiclone	Preferred Pharmaceuticals Inc.	2026-04-14	HUMAN PRESCRIPTION DRUG LABEL	9
Eszopiclone	REMEDYREPACK INC.	2026-04-13	HUMAN PRESCRIPTION DRUG LABEL	5
Eszopiclone	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-02-12	HUMAN PRESCRIPTION DRUG LABEL	2
Eszopiclone Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	6
Eszopiclone	Quality Care Products LLC	2024-12-17	Human Prescription Drug Label	6
Eszopiclone	Bryant Ranch Prepack	2024-08-07	Human Prescription Drug Label	21
Eszopiclone	NuCarePharmaceuticals, Inc. \| NuCare Pharmaceuticals, Inc.	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL	4
Eszopiclone	Proficient Rx LP	2023-07-01	HUMAN PRESCRIPTION DRUG LABEL	5
ESZOPICLONE 3MG	DIRECT RX	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL	3
Eszopiclone	St. Mary's Medical Park Pharmacy	2022-12-22	HUMAN PRESCRIPTION DRUG LABEL	2
Eszopiclone	Macleods Pharmaceuticals Limited	2022-10-29	Human Prescription Drug Label	9
Eszopiclone	Unit Dose Services	2017-11-09	Human Prescription Drug Label	7
Eszopiclone	Aidarex Pharmaceuticals LLC	2017-03-02	HUMAN PRESCRIPTION DRUG LABEL	1