Eszopiclone

Product NDC: 68071-3376
11-digit product format: 680713376
Labeler code: 68071
Product ID: 68071-3376_1ce8fd7d-c659-0b3f-e063-6394a90ae539
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eszopiclone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCarePharmaceuticals, Inc.
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

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-3376-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-3376-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-3376-3	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-3376-3	`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
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…`

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 · 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
53fcee89-027a-13e5-e054-00144ff8d46c	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-07-10	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
2023-01-30	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
2021-02-12	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
2021-01-29	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
68071-3376-3	Eszopiclone	30 in 1 BOTTLE	TABLET, FILM COATED	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3376	ESZOPICLONE TABLET, FILM COATED [NUCAREPHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20240711_53fcee89-027a-13e5-e054-00144ff8d46c.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 ndc (product): 68071-3376
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

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	53fcee89-027a-13e5-e054-00144ff8d46c	4
485465	eszopiclone 3 MG Oral Tablet	SCD	53fcee89-027a-13e5-e054-00144ff8d46c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-3376-3	68071337603	30 TABLET, FILM COATED in 1 BOTTLE (68071-3376-3)	2017-07-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eszopiclone	NuCarePharmaceuticals, Inc. \| NuCare Pharmaceuticals, Inc.	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL	4