Eszopiclone

Product NDC: 68180-322
11-digit product format: 681800322
Labeler code: 68180
Product ID: 68180-322_a3530781-6fea-425f-9958-eeb2d0b3c696
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eszopiclone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA091124
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: 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	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 · 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`8072bd15b7f6…`

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…`

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 · 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
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 ndc (product): 68180-322

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 · 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
7068c455-691e-4c56-9857-b7b4e13f4784	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
68180-322-01	Eszopiclone	100 in 1 BOTTLE	TABLET, FILM COATED	100		15
68180-322-11	Eszopiclone	14 in 1 BLISTER PACK	TABLET, FILM COATED	14		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-322-01	EA - Each	68180-322	e79bedf2-dbe3-4fd3-a35d-959e4aac7524	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 [LUPIN PHARMACEUTICALS, INC.]	4
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	4
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	4
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	4
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	4
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-322	ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	15	Current NDC, Legacy NDC, 2 package rows	20240118_7068c455-691e-4c56-9857-b7b4e13f4784.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
485440	eszopiclone 1 MG Oral Tablet	PSN	7068c455-691e-4c56-9857-b7b4e13f4784	15
485442	eszopiclone 2 MG Oral Tablet	PSN	7068c455-691e-4c56-9857-b7b4e13f4784	15
485465	eszopiclone 3 MG Oral Tablet	PSN	7068c455-691e-4c56-9857-b7b4e13f4784	15
485440	eszopiclone 1 MG Oral Tablet	SCD	7068c455-691e-4c56-9857-b7b4e13f4784	15
485442	eszopiclone 2 MG Oral Tablet	SCD	7068c455-691e-4c56-9857-b7b4e13f4784	15
485465	eszopiclone 3 MG Oral Tablet	SCD	7068c455-691e-4c56-9857-b7b4e13f4784	15
485440	eszopiclone 1 MG Oral Tablet	PSN	b39dc64d-adc9-742e-e053-2a95a90ad18b	5
485440	eszopiclone 1 MG Oral Tablet	SCD	b39dc64d-adc9-742e-e053-2a95a90ad18b	5
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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-322-01	68180032201	100 TABLET, FILM COATED in 1 BOTTLE (68180-322-01)		2014-04-15	0000-00-00	No	No	Current
68180-322-11	68180032211	14 in 1 BLISTER PACK						Historical
68180-322-13	68180032213	7 BLISTER PACK in 1 CARTON (68180-322-13) > 14 TABLET, FILM COATED in 1 BLISTER PACK (68180-322-11)	7 blister pack	2014-04-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ESZOPICLONE - DIRECT RX	DIRECT RX	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	3
Eszopiclone Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	5
Eszopiclone	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2024-01-17	HUMAN PRESCRIPTION DRUG LABEL	15