ESZOPICLONE

Product NDC: 45865-829
11-digit product format: 458650829
Labeler code: 45865
Product ID: 45865-829_9ab48833-f4f1-89fc-e053-2995a90a7d67
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESZOPICLONE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA091103
Marketing category: ANDA
Marketing start: 2014-04-15
Marketing end: 0000-00-00
Substance: ESZOPICLONE
Active strength: 2 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	45865-829		I	Inactivated by FDA	2026-08-03
excluded package	package	45865-829	45865-829-20	I	Inactivated by FDA	2026-08-03
excluded package	package	45865-829	45865-829-30	I	Inactivated by FDA	2026-08-03
excluded package	package	45865-829	45865-829-60	I	Inactivated by FDA	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 · 36 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 17:58 UTC · source 2025-12-05	excluded product	product	45865-829		I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-829	45865-829-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-829	45865-829-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-829	45865-829-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	45865-829		I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-829	45865-829-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-829	45865-829-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-829	45865-829-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	45865-829		I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-829	45865-829-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-829	45865-829-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-829	45865-829-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	45865-829		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-829	45865-829-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-829	45865-829-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-829	45865-829-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	45865-829		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-829	45865-829-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-829	45865-829-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-829	45865-829-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	45865-829		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-829	45865-829-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-829	45865-829-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-829	45865-829-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	45865-829		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-829	45865-829-20	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-829	45865-829-30	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-829	45865-829-60	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	45865-829		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-829	45865-829-20	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-829	45865-829-30	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-829	45865-829-60	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	45865-829		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-829	45865-829-20	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-829	45865-829-30	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-829	45865-829-60	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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#

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 · 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
45865-829-20	2025-01-30	C162847	48780-1	2cef2736-942a-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004
45865-829-30	2025-01-30	C162847	48780-1	2cef2736-942a-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004
45865-829-60	2025-01-30	C162847	48780-1	2cef2736-942a-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
45865-829-20	ESZOPICLONE	20 in 1 BOTTLE	TABLET, FILM COATED	20	3
45865-829-30	ESZOPICLONE	30 in 1 BOTTLE	TABLET, FILM COATED	30	3
45865-829-60	ESZOPICLONE	60 in 1 BOTTLE	TABLET, FILM COATED	60	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESZOPICLONE	ACTIVE INGREDIENT	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-829	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	3	Legacy NDC, 3 package rows	20191228_1bbd525e-be06-310d-e054-00144ff88e88.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	1bbd525e-be06-310d-e054-00144ff88e88	3
485442	eszopiclone 2 MG Oral Tablet	PSN	1bbd525e-be06-310d-e054-00144ff88e88	3
485465	eszopiclone 3 MG Oral Tablet	PSN	1bbd525e-be06-310d-e054-00144ff88e88	3
485440	eszopiclone 1 MG Oral Tablet	SCD	1bbd525e-be06-310d-e054-00144ff88e88	3
485442	eszopiclone 2 MG Oral Tablet	SCD	1bbd525e-be06-310d-e054-00144ff88e88	3
485465	eszopiclone 3 MG Oral Tablet	SCD	1bbd525e-be06-310d-e054-00144ff88e88	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-829-20	45865082920	20 TABLET, FILM COATED in 1 BOTTLE (45865-829-20)	2015-07-27	0000-00-00	No	No	Current
45865-829-30	45865082930	30 TABLET, FILM COATED in 1 BOTTLE (45865-829-30)	2015-07-27	0000-00-00	No	No	Current
45865-829-60	45865082960	60 TABLET, FILM COATED in 1 BOTTLE (45865-829-60)	2015-07-27	0000-00-00	No	No	Current