Eszopiclone

Product NDC: 68462-383
11-digit product format: 684620383
Labeler code: 68462
Product ID: 68462-383_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: 2 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 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 3 · 99 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
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 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…`
2024-05-31 18:47 UTC	2024-05	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091166-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-04-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091166-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091166-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-04-15	`5aa47cf7b7d7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A091166-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A091166-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 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…`
2024-05-31 18:47 UTC	2024-05	A091166-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091166-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091166-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091166-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091166-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091166-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091166-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091166-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091166-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091166-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091166-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091166-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091166-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091166-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091166-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091166-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091166-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091166-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091166-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091166-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091166-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091166-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091166-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091166-001	AB	1	`5aa47cf7b7d7…`

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 ndc (product): 68462-383
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESZOPICLONE	2 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	Strength	SPL version
68462-383-01	Eszopiclone	100 in 1 BOTTLE	TABLET, FILM COATED	100		11
68462-383-10	Eszopiclone	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-383-01	EA - Each	68462-383	48a6736e-73bf-420e-b0e6-34f6eff9a7b9	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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-383	ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC. USA]	10	Current NDC, Legacy NDC, 2 package rows	20230116_584dc66c-063a-4552-a056-74b811e2bc80.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	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
485442	eszopiclone 2 MG Oral Tablet	PSN	dc8db885-e4ef-4d72-9808-c5b2af258659	3
485465	eszopiclone 3 MG Oral Tablet	PSN	dc8db885-e4ef-4d72-9808-c5b2af258659	3
485442	eszopiclone 2 MG Oral Tablet	SCD	dc8db885-e4ef-4d72-9808-c5b2af258659	3
485465	eszopiclone 3 MG Oral Tablet	SCD	dc8db885-e4ef-4d72-9808-c5b2af258659	3
485440	eszopiclone 1 MG Oral Tablet	PSN	838559f7-4b69-4831-bf50-ab37c6c24c2b	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
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
485442	eszopiclone 2 MG Oral Tablet	PSN	c4ff1d6a-918e-c046-e053-2a95a90a9c9b	1
485442	eszopiclone 2 MG Oral Tablet	PSN	e32746a8-6440-4b0a-a445-4467cf0329d5	1
485442	eszopiclone 2 MG Oral Tablet	SCD	e32746a8-6440-4b0a-a445-4467cf0329d5	1
485442	eszopiclone 2 MG Oral Tablet	SCD	c4ff1d6a-918e-c046-e053-2a95a90a9c9b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-383-01	68462038301	100 TABLET, FILM COATED in 1 BOTTLE (68462-383-01)	2014-04-15	0000-00-00	No	No	Current
68462-383-10	68462038310	1000 TABLET, FILM COATED in 1 BOTTLE (68462-383-10)	2014-04-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eszopiclone	St Mary's Medical Park Pharmacy	2026-06-20	HUMAN PRESCRIPTION DRUG LABEL	2
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	Preferred Pharmaceuticals Inc. USA	2025-05-02	HUMAN PRESCRIPTION DRUG LABEL	5
Eszopiclone	Bryant Ranch Prepack	2024-08-23	HUMAN PRESCRIPTION DRUG LABEL	12
Eszopiclone	Proficient Rx LP	2024-02-01	HUMAN PRESCRIPTION DRUG LABEL	1
Eszopiclone	Unit Dose Services	2022-01-10	HUMAN PRESCRIPTION DRUG LABEL	3