ESZOPICLONE

Product NDC: 61919-502
11-digit product format: 619190502
Labeler code: 61919
Product ID: 61919-502_6db26b35-5c99-412a-b880-37e5b713a9da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESZOPICLONE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA091103
Marketing category: ANDA
Marketing start: 2015-01-01
Marketing end: 0000-00-00
Substance: ESZOPICLONE
Active strength: 1 mg/1
DEA schedule: CIV
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-502		I	Inactivated by FDA	2026-08-03
excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-502	61919-502-60	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 2 · 66 matching rows.

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

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 17:58 UTC · source 2025-12-05	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	61919-502		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-502	61919-502-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-502	61919-502-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`

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
A091103-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03
A091103-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03
A091103-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091103-001	AB
A091103-002	AB
A091103-003	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	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`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	A091103-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091103-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091103-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091103-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091103-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091103-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091103-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091103-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091103-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091103-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091103-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091103-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091103-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091103-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091103-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091103-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091103-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091103-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091103-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091103-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091103-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091103-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091103-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091103-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091103-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091103-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091103-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091103-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091103-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091103-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091103-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091103-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091103-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091103-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091103-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091103-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091103-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091103-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091103-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091103-001	AB	1	`8072bd15b7f6…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ESZOPICLONE	ESZOPICLONE	Sun Pharmaceutical Industries, Inc.	8bb1965e-7845-4c5b-b021-38e251303d68	2018-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091103 application number: ANDA091103

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
61919-502-30	2020-01-31	C162847	48780-1	9d75b9d0-fe38-f424-e053-dadaa90a57ce	ESZOPICLONE
61919-502-60	2020-01-31	C162847	48780-1	9d75b9d0-fe38-f424-e053-dadaa90a57ce	ESZOPICLONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-502-30	ESZOPICLONE	30 in 1 BOTTLE	TABLET, FILM COATED	30		2
61919-502-60	ESZOPICLONE	60 in 1 BOTTLE	TABLET, FILM COATED	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-502-30	EA - Each	61919-502	2d0c31d2-7853-40a4-941d-c670d6d8d4e9	1	2015-10-02
61919-502-60	EA - Each	61919-502	d9ec86f3-f46f-497e-b655-2156edfee650	1	2016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESZOPICLONE	ACTIVE INGREDIENT	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-502	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2	Legacy NDC, 2 package rows	20150810_b8cd6577-17e7-4808-a9a8-3f65444c51cb.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	b8cd6577-17e7-4808-a9a8-3f65444c51cb	2
485440	eszopiclone 1 MG Oral Tablet	SCD	b8cd6577-17e7-4808-a9a8-3f65444c51cb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-502-30	61919050230	30 in 1 BOTTLE	Historical
61919-502-60	61919050260	60 in 1 BOTTLE	Historical