Eszopiclone

Product NDC: 68462-382
11-digit product format: 684620382
Labeler code: 68462
Product ID: 68462-382_59fb9200-74d0-472d-a4c7-96c9a4ded89c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eszopiclone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc. USA
Application: ANDA091166
Marketing category: ANDA
Marketing start: 2014-04-15
Substance: ESZOPICLONE
Active strength: 1 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2027-12-31
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
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 · 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	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`caaa826d4ba7…`
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…`

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	A091166-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091166-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091166-003	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Eszopiclone
Listing expiration: 2027-12-31

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 · 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
584dc66c-063a-4552-a056-74b811e2bc80	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
68462-382-01	Eszopiclone	100 in 1 BOTTLE	TABLET, FILM COATED	100	11
68462-382-10	Eszopiclone	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	11
68462-382-30	Eszopiclone	30 in 1 BOTTLE	TABLET, FILM COATED	30	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-382-01	EA - Each	68462-382	059bfbb4-2b01-4ff7-a83a-9b70e1b75d6d	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESZOPICLONE	ACTIVE INGREDIENT	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	3
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	3
ESZOPICLONE	ACTIVE INGREDIENT	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	1
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-382	ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC. USA]	10	Current NDC, Legacy NDC, 3 package rows	20230116_584dc66c-063a-4552-a056-74b811e2bc80.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 · 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 ndc (product): 68462-382
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
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

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	d1baa5ba-73ac-462b-a728-217d5992674a	12
485442	eszopiclone 2 MG Oral Tablet	PSN	d1baa5ba-73ac-462b-a728-217d5992674a	12
485440	eszopiclone 1 MG Oral Tablet	SCD	d1baa5ba-73ac-462b-a728-217d5992674a	12
485442	eszopiclone 2 MG Oral Tablet	SCD	d1baa5ba-73ac-462b-a728-217d5992674a	12
485440	eszopiclone 1 MG Oral Tablet	PSN	584dc66c-063a-4552-a056-74b811e2bc80	11
485442	eszopiclone 2 MG Oral Tablet	PSN	584dc66c-063a-4552-a056-74b811e2bc80	11
485465	eszopiclone 3 MG Oral Tablet	PSN	584dc66c-063a-4552-a056-74b811e2bc80	11
485440	eszopiclone 1 MG Oral Tablet	SCD	584dc66c-063a-4552-a056-74b811e2bc80	11
485442	eszopiclone 2 MG Oral Tablet	SCD	584dc66c-063a-4552-a056-74b811e2bc80	11
485465	eszopiclone 3 MG Oral Tablet	SCD	584dc66c-063a-4552-a056-74b811e2bc80	11
485440	eszopiclone 1 MG Oral Tablet	PSN	0102ea59-77b1-4e74-83ec-1d205563b55f	4
485440	eszopiclone 1 MG Oral Tablet	PSN	25eb24c7-0529-6eec-e054-00144ff8d46c	4
485440	eszopiclone 1 MG Oral Tablet	SCD	0102ea59-77b1-4e74-83ec-1d205563b55f	4
485440	eszopiclone 1 MG Oral Tablet	SCD	25eb24c7-0529-6eec-e054-00144ff8d46c	4
485440	eszopiclone 1 MG Oral Tablet	PSN	838559f7-4b69-4831-bf50-ab37c6c24c2b	2
485440	eszopiclone 1 MG Oral Tablet	PSN	edc03482-b013-448a-8cd9-2a17bd6d15e9	2
485442	eszopiclone 2 MG Oral Tablet	PSN	838559f7-4b69-4831-bf50-ab37c6c24c2b	2
485465	eszopiclone 3 MG Oral Tablet	PSN	838559f7-4b69-4831-bf50-ab37c6c24c2b	2
485440	eszopiclone 1 MG Oral Tablet	SCD	838559f7-4b69-4831-bf50-ab37c6c24c2b	2
485440	eszopiclone 1 MG Oral Tablet	SCD	edc03482-b013-448a-8cd9-2a17bd6d15e9	2
485442	eszopiclone 2 MG Oral Tablet	SCD	838559f7-4b69-4831-bf50-ab37c6c24c2b	2
485465	eszopiclone 3 MG Oral Tablet	SCD	838559f7-4b69-4831-bf50-ab37c6c24c2b	2
485440	eszopiclone 1 MG Oral Tablet	PSN	397a8650-84fa-43ef-9006-922a39bc0b1d	1
485440	eszopiclone 1 MG Oral Tablet	PSN	2af5d70c-61ee-4285-8183-aab4f8dccad0	1
485440	eszopiclone 1 MG Oral Tablet	PSN	1baa56e5-34d5-c8a1-e063-6394a90ae6c7	1
485440	eszopiclone 1 MG Oral Tablet	SCD	397a8650-84fa-43ef-9006-922a39bc0b1d	1
485440	eszopiclone 1 MG Oral Tablet	SCD	2af5d70c-61ee-4285-8183-aab4f8dccad0	1
485440	eszopiclone 1 MG Oral Tablet	SCD	1baa56e5-34d5-c8a1-e063-6394a90ae6c7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-382-01	68462038201	100 TABLET, FILM COATED in 1 BOTTLE (68462-382-01)	2014-04-15	0000-00-00	No	No	Current
68462-382-10	68462038210	1000 TABLET, FILM COATED in 1 BOTTLE (68462-382-10)	2014-04-15	0000-00-00	No	No	Current
68462-382-30	68462038230	30 TABLET, FILM COATED in 1 BOTTLE (68462-382-30)	2014-04-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eszopiclone	Preferred Pharmaceuticals Inc.	2026-04-13	HUMAN PRESCRIPTION DRUG LABEL	4
Eszopiclone	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-03-10	HUMAN PRESCRIPTION DRUG LABEL	2
Eszopiclone	Glenmark Pharmaceuticals Inc. USA \| Glenmark Pharmaceuticals Limited	2026-01-30	HUMAN PRESCRIPTION DRUG LABEL	11
Eszopiclone	Bryant Ranch Prepack	2024-08-23	HUMAN PRESCRIPTION DRUG LABEL	12
Eszopiclone	Advanced Rx of Tennessee, LLC	2024-06-24	HUMAN PRESCRIPTION DRUG LABEL	1
Eszopiclone	Proficient Rx LP	2022-05-01	HUMAN PRESCRIPTION DRUG LABEL	2
ESZOPICLONE	DirectRX	2022-02-08	HUMAN PRESCRIPTION DRUG LABEL	4
Eszopiclone	Preferred Pharmaceuticals, Inc.	2019-09-10	HUMAN PRESCRIPTION DRUG LABEL	5
Eszopiclone	A-S Medication Solutions	2019-01-02	HUMAN PRESCRIPTION DRUG LABEL	1
Eszopiclone	Aidarex Pharmaceuticals LLC	2017-03-02	HUMAN PRESCRIPTION DRUG LABEL	1