ESZOPICLONE

Product NDC: 61919-462
Requested package NDC: 61919-462-30
11-digit product format: 619190462
Labeler code: 61919
Product ID: 61919-462_9c9402dc-ee1c-6c1f-e053-2995a90adabd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESZOPICLONE
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA091153
Marketing category: ANDA
Marketing start: 2018-03-12
Marketing end: 0000-00-00
Substance: ESZOPICLONE
Active strength: 3 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-462	61919-462-30	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A091153-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15
A091153-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15
A091153-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A091153-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091153-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091153-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A091153-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091153-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091153-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091153-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091153-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091153-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091153-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091153-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091153-003	AB	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f65008ed-f925-2246-581a-e6a3201df7e4	Product name	5	20250107

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-462-30	2023-01-30	C162847	48780-1	f386c649-b0f0-0266-e053-dadaa90a7c1a	ESZOPICLONE 3MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-462-30	ESZOPICLONE	30 in 1 BOTTLE	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-462-30	EA - Each	61919-462	ded46444-ee3b-4055-963e-c6a9ab0e3ec1	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-462	ESZOPICLONE TABLET [DIRECT RX]	2	Legacy NDC, 1 package rows	20200121_673b7e99-1cbb-e888-e053-2a91aa0addc1.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	673b7e99-1cbb-e888-e053-2a91aa0addc1	2
485465	eszopiclone 3 MG Oral Tablet	SCD	673b7e99-1cbb-e888-e053-2a91aa0addc1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-462-30	61919046230	30 TABLET in 1 BOTTLE (61919-462-30)	30 tablet	2018-03-12	0000-00-00	No	No	Current