ESZOPICLONE

Product NDC: 63629-5325
11-digit product format: 636295325
Labeler code: 63629
Product ID: 63629-5325_f19a9ea1-faf6-4b24-bfed-70a78d77febb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESZOPICLONE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA091103
Marketing category: ANDA
Marketing start: 2014-04-15
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-5325		D	Discontinued by firm	2026-08-03
excluded package	package	63629-5325	63629-5325-1	D	Discontinued by firm	2026-08-03
excluded package	package	63629-5325	63629-5325-2	D	Discontinued by firm	2026-08-03
excluded package	package	63629-5325	63629-5325-3	D	Discontinued by firm	2026-08-03
excluded package	package	63629-5325	63629-5325-4	D	Discontinued by firm	2026-08-03
excluded package	package	63629-5325	63629-5325-5	D	Discontinued by firm	2026-08-03
excluded package	package	63629-5325	63629-5325-6	D	Discontinued by firm	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 · 90 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-5325-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-5325-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-5325-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-5325-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-5325-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-5325-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-5325-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-5325-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-5325-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-5325-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-5325-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-5325-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-5325-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-5325-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-5325-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-5325-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-5325-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-5325-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-5325-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-5325-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-5325-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-5325-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-5325-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-5325-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-5325-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-5325-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-5325-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-5325-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-5325-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-5325-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-5325-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-5325-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-5325-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-5325-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-5325-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-5325-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-5325-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-5325-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-5325-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-5325-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-5325-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-5325-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-5325-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-5325-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-5325-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-5325-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-5325-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-5325-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-5325-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-5325-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-5325-5	`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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-5325-1	2019-12-11	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
63629-5325-2	2019-12-11	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
63629-5325-3	2019-12-11	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
63629-5325-4	2019-12-11	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
63629-5325-5	2019-12-11	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
63629-5325-1	2019-11-27	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
63629-5325-2	2019-11-27	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
63629-5325-3	2019-11-27	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
63629-5325-4	2019-11-27	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
63629-5325-5	2019-11-27	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 Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESZOPICLONE	ACTIVE INGREDIENT	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001

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