ESZOPICLONE

Product NDC: 72789-067
11-digit product format: 727890067
Labeler code: 72789
Product ID: 72789-067_403149fb-ab38-8d11-e063-6294a90a14a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESZOPICLONE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA208451
Marketing category: ANDA
Marketing start: 2016-09-15
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 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
A208451-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15
A208451-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15
A208451-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208451-001	AB
A208451-002	AB
A208451-003	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	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`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	A208451-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208451-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208451-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208451-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208451-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208451-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208451-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208451-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208451-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208451-001	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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ESZOPICLONE	ESZOPICLONE	Preferred Pharmaceuticals, Inc.	45558f0a-83f1-49b9-ab18-f436c0be9677	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	REMEDYREPACK INC.	7df922bc-5750-4259-906f-64f960c38d5f	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	A-S Medication Solutions	57a8450c-59ee-4c96-bef4-308fa7b97d1e	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	A-S Medication Solutions	bfa767ce-340b-4d3a-a9c7-0043b6d7ff6e	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	A-S Medication Solutions	e261bf7f-1b89-4393-8c48-4e72fc29192f	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	A-S Medication Solutions	923cc646-f22a-4a26-88f7-a19fce016321	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	PD-Rx Pharmaceuticals, Inc.	bb972d36-4b2c-45ae-8504-3a16d352dd8b	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451 ndc (product): 72789-067
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	af869866-0a11-1a05-e053-2a95a90acdb8	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	af86fca8-571e-0cac-e053-2a95a90ae402	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	39b96725-2a01-4d9f-a56d-af7491b3b601	2023-11-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	Proficient Rx LP	2f4fa6e8-be82-4fb5-9a11-9ba8f557c027	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	Proficient Rx LP	024f833e-c20c-46a2-971b-3f2a716b1678	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	Aurobindo Pharma Limited	f18cc76f-82aa-4ad7-b8ce-5737733ee104	2021-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	Proficient Rx LP	bad8fe65-73c1-4542-8050-720af889905a	2020-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451

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
bb972d36-4b2c-45ae-8504-3a16d352dd8b	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72789-067-30	ESZOPICLONE	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-067-30	EA - Each	72789-067	fd7afc59-3b94-4bd8-9afc-f3da4865c9b3	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-067	ESZOPICLONE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	15	Current NDC, Legacy NDC, 1 package rows	20241010_bb972d36-4b2c-45ae-8504-3a16d352dd8b.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	bb972d36-4b2c-45ae-8504-3a16d352dd8b	16
485465	eszopiclone 3 MG Oral Tablet	SCD	bb972d36-4b2c-45ae-8504-3a16d352dd8b	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-067-30	72789006730	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-067-30)	2020-03-26	0000-00-00	No	No	Current