ESZOPICLONE

Product NDC: 72189-099
11-digit product format: 721890099
Labeler code: 72189
Product ID: 72189-099_2be80953-8e55-14bd-e063-6294a90a4fae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESZOPICLONE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA091124
Marketing category: ANDA
Marketing start: 2020-06-10
Substance: ESZOPICLONE
Active strength: 1 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 · 3 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
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	72189-099		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-099	72189-099-30	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-099	72189-099-90	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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	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 · 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	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL		2011-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL		2011-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL		2011-09-13	`caaa826d4ba7…`
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…`

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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESZOPICLONE	1 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
485440	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
a7bd3e3c-26e9-07e7-e053-2995a90a9ca5	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	Strength	SPL version
72189-099-30	ESZOPICLONE	30 in 1 BOTTLE	TABLET, FILM COATED	30		3
72189-099-90	ESZOPICLONE	90 in 1 BOTTLE	TABLET, FILM COATED	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-099-30	EA - Each	72189-099	89e7faac-b8f1-4d87-a544-064e0c8f7db6	1	2020-07-13
72189-099-90	EA - Each	72189-099	3062bee3-fe48-4bff-97cc-b0ea802a32df	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-099	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	3	Current NDC, Legacy NDC, 2 package rows	20250119_a7bd3e3c-26e9-07e7-e053-2995a90a9ca5.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 · 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 ndc (product): 72189-099
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

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	a7bd3e3c-26e9-07e7-e053-2995a90a9ca5	3
485440	eszopiclone 1 MG Oral Tablet	SCD	a7bd3e3c-26e9-07e7-e053-2995a90a9ca5	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-099-30	72189009930	30 TABLET, FILM COATED in 1 BOTTLE (72189-099-30)	2020-06-10	0000-00-00	No	No	Current
72189-099-90	72189009990	90 TABLET, FILM COATED in 1 BOTTLE (72189-099-90)	2020-06-10	0000-00-00	No	No	Current