Eszopiclone

Product NDC: 71205-633
Requested package NDC: 71205-633-90
11-digit product format: 712050633
Labeler code: 71205
Product ID: 71205-633_5381d4b2-e743-4ece-9fe3-e2be6eb85711
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eszopiclone
Dosage form: TABLET, FILM COATED
Route: OROPHARYNGEAL
Labeler: Proficient Rx LP
Application: ANDA091166
Marketing category: ANDA
Marketing start: 2014-04-15
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
A091166-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15
A091166-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15
A091166-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091166-001	AB
A091166-002	AB
A091166-003	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	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`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	A091166-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091166-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091166-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091166-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091166-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091166-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091166-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091166-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091166-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091166-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091166-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091166-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091166-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091166-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091166-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091166-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091166-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091166-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091166-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091166-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091166-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091166-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091166-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091166-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091166-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091166-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091166-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091166-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091166-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091166-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091166-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091166-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091166-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091166-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091166-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091166-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091166-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091166-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091166-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091166-001	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eszopiclone	ESZOPICLONE	St Mary's Medical Park Pharmacy	c4ff1d6a-918e-c046-e053-2a95a90a9c9b	2026-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	Bryant Ranch Prepack	e04d4f8b-c9a1-4dc9-aac4-2e6376cd9a0c	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	Preferred Pharmaceuticals Inc.	0102ea59-77b1-4e74-83ec-1d205563b55f	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	NuCare Pharmaceuticals,Inc.	c24ec179-f869-746f-e053-2995a90aa1ff	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	Asclemed USA, Inc.	838559f7-4b69-4831-bf50-ab37c6c24c2b	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	Glenmark Pharmaceuticals Inc. USA	584dc66c-063a-4552-a056-74b811e2bc80	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	Bryant Ranch Prepack	d1baa5ba-73ac-462b-a728-217d5992674a	2024-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	1baa56e5-34d5-c8a1-e063-6394a90ae6c7	2024-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	Proficient Rx LP	e32746a8-6440-4b0a-a445-4467cf0329d5	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166
Eszopiclone	ESZOPICLONE	Proficient Rx LP	ac996f97-fd92-44f8-8bb5-478a81ffb33d	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166 ndc (package): 71205-633-90 ndc (product): 71205-633 ndc11 (package): 71205063390
Eszopiclone	ESZOPICLONE	Proficient Rx LP	edc03482-b013-448a-8cd9-2a17bd6d15e9	2022-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091166 application number: ANDA091166

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
ac996f97-fd92-44f8-8bb5-478a81ffb33d	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
71205-633-30	Eszopiclone	30 in 1 BOTTLE	TABLET, FILM COATED	30	3
71205-633-60	Eszopiclone	60 in 1 BOTTLE	TABLET, FILM COATED	60	3
71205-633-90	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
71205-633-30	EA - Each	71205-633	d1f4f848-d901-4552-ae9b-50eea33ce185	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-633	ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 3 package rows	20220709_ac996f97-fd92-44f8-8bb5-478a81ffb33d.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	ac996f97-fd92-44f8-8bb5-478a81ffb33d	3
485465	eszopiclone 3 MG Oral Tablet	SCD	ac996f97-fd92-44f8-8bb5-478a81ffb33d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-633-90	71205063390	90 TABLET, FILM COATED in 1 BOTTLE (71205-633-90)	2022-01-20	0000-00-00	No	No	Current