ESZOPICLONE

Product NDC: 65862-969
11-digit product format: 658620969
Labeler code: 65862
Product ID: 65862-969_a39aa520-c8ad-4f39-ad71-04a839474b5b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESZOPICLONE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA208451
Marketing category: ANDA
Marketing start: 2016-09-15
Substance: ESZOPICLONE
Active strength: 3 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing		2026-08-03
unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 42 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product	65862-969		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	65862-969	65862-969-49	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A208451-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15
A208451-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15
A208451-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208451-001	AB
A208451-002	AB
A208451-003	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	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2016-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2016-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208451-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2016-09-15	`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	A208451-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208451-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208451-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208451-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208451-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208451-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208451-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208451-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208451-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208451-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208451-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208451-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208451-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208451-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208451-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208451-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208451-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208451-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208451-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208451-001	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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ESZOPICLONE	ESZOPICLONE	Preferred Pharmaceuticals, Inc.	45558f0a-83f1-49b9-ab18-f436c0be9677	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	REMEDYREPACK INC.	7df922bc-5750-4259-906f-64f960c38d5f	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	A-S Medication Solutions	57a8450c-59ee-4c96-bef4-308fa7b97d1e	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	A-S Medication Solutions	bfa767ce-340b-4d3a-a9c7-0043b6d7ff6e	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	A-S Medication Solutions	e261bf7f-1b89-4393-8c48-4e72fc29192f	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	A-S Medication Solutions	923cc646-f22a-4a26-88f7-a19fce016321	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	PD-Rx Pharmaceuticals, Inc.	bb972d36-4b2c-45ae-8504-3a16d352dd8b	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	af869866-0a11-1a05-e053-2a95a90acdb8	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	af86fca8-571e-0cac-e053-2a95a90ae402	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	39b96725-2a01-4d9f-a56d-af7491b3b601	2023-11-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	Proficient Rx LP	2f4fa6e8-be82-4fb5-9a11-9ba8f557c027	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	Proficient Rx LP	024f833e-c20c-46a2-971b-3f2a716b1678	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451
ESZOPICLONE	ESZOPICLONE	Aurobindo Pharma Limited	f18cc76f-82aa-4ad7-b8ce-5737733ee104	2021-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451 ndc (product): 65862-969
ESZOPICLONE	ESZOPICLONE	Proficient Rx LP	bad8fe65-73c1-4542-8050-720af889905a	2020-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208451 application number: ANDA208451

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 · 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
f18cc76f-82aa-4ad7-b8ce-5737733ee104	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65862-969-01	ESZOPICLONE	100 in 1 BOTTLE	TABLET, FILM COATED	100		9
65862-969-30	ESZOPICLONE	30 in 1 BOTTLE	TABLET, FILM COATED	30		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-969-01	EA - Each	65862-969	fd0e8c57-9969-44f2-80bf-366094caa728	1	2016-12-07
65862-969-30	EA - Each	65862-969	50b79976-55c9-44ee-82b3-f2119e762a2b	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-969	ESZOPICLONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	9	Current NDC, Legacy NDC, 2 package rows	20220301_f18cc76f-82aa-4ad7-b8ce-5737733ee104.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	bb972d36-4b2c-45ae-8504-3a16d352dd8b	16
485465	eszopiclone 3 MG Oral Tablet	SCD	bb972d36-4b2c-45ae-8504-3a16d352dd8b	16
485465	eszopiclone 3 MG Oral Tablet	PSN	57a8450c-59ee-4c96-bef4-308fa7b97d1e	10
485465	eszopiclone 3 MG Oral Tablet	SCD	57a8450c-59ee-4c96-bef4-308fa7b97d1e	10
485440	eszopiclone 1 MG Oral Tablet	PSN	f18cc76f-82aa-4ad7-b8ce-5737733ee104	9
485442	eszopiclone 2 MG Oral Tablet	PSN	f18cc76f-82aa-4ad7-b8ce-5737733ee104	9
485465	eszopiclone 3 MG Oral Tablet	PSN	f18cc76f-82aa-4ad7-b8ce-5737733ee104	9
485440	eszopiclone 1 MG Oral Tablet	SCD	f18cc76f-82aa-4ad7-b8ce-5737733ee104	9
485442	eszopiclone 2 MG Oral Tablet	SCD	f18cc76f-82aa-4ad7-b8ce-5737733ee104	9
485465	eszopiclone 3 MG Oral Tablet	SCD	f18cc76f-82aa-4ad7-b8ce-5737733ee104	9
485465	eszopiclone 3 MG Oral Tablet	PSN	af869866-0a11-1a05-e053-2a95a90acdb8	5
485465	eszopiclone 3 MG Oral Tablet	SCD	af869866-0a11-1a05-e053-2a95a90acdb8	5
485465	eszopiclone 3 MG Oral Tablet	PSN	2f4fa6e8-be82-4fb5-9a11-9ba8f557c027	4
485465	eszopiclone 3 MG Oral Tablet	SCD	2f4fa6e8-be82-4fb5-9a11-9ba8f557c027	4
485465	eszopiclone 3 MG Oral Tablet	PSN	e261bf7f-1b89-4393-8c48-4e72fc29192f	1
485465	eszopiclone 3 MG Oral Tablet	SCD	e261bf7f-1b89-4393-8c48-4e72fc29192f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-969-01	65862096901	100 TABLET, FILM COATED in 1 BOTTLE (65862-969-01)	2016-09-15	0000-00-00	No	No	Current
65862-969-30	65862096930	30 TABLET, FILM COATED in 1 BOTTLE (65862-969-30)	2016-09-15	0000-00-00	No	No	Current
65862-969-49	65862096949	4000 TABLET, FILM COATED in 1 BAG (65862-969-49)	15-SEP-16				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ESZOPICLONE	A-S Medication Solutions	2025-11-07	Human Prescription Drug Label	10
ESZOPICLONE	A-S Medication Solutions	2025-11-05	Human Prescription Drug Label	1
ESZOPICLONE	PD-Rx Pharmaceuticals, Inc.	2025-10-02	HUMAN PRESCRIPTION DRUG LABEL	16
Eszopiclone Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	5
ESZOPICLONE	REMEDYREPACK INC.	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	3
ESZOPICLONE	Proficient Rx LP	2022-08-01	HUMAN PRESCRIPTION DRUG LABEL	4
ESZOPICLONE	Aurobindo Pharma Limited	2021-12-27	Human Prescription Drug Label	9