ESZOPICLONE

Product NDC: 42043-321
Requested package NDC: 42043-321-01
11-digit product format: 420430321
Labeler code: 42043
Product ID: 42043-321_7520c868-9116-455c-be63-006171333465
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESZOPICLONE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: OrchidPharma Inc
Application: ANDA091113
Marketing category: ANDA
Marketing start: 2014-09-25
Marketing end: 0000-00-00
Substance: ESZOPICLONE
Active strength: 2 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

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

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	42043-321	42043-321-01	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 1 · 15 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 package	package	42043-321	42043-321-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42043-321	42043-321-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42043-321	42043-321-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42043-321	42043-321-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42043-321	42043-321-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42043-321	42043-321-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42043-321	42043-321-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42043-321	42043-321-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42043-321	42043-321-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42043-321	42043-321-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42043-321	42043-321-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42043-321	42043-321-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42043-321	42043-321-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42043-321	42043-321-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42043-321	42043-321-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091113-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10
A091113-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10
A091113-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091113-001	AB
A091113-002	AB
A091113-003	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	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`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	A091113-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091113-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091113-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091113-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091113-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091113-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091113-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091113-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091113-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091113-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091113-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091113-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091113-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091113-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091113-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091113-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091113-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091113-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091113-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091113-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091113-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091113-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091113-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091113-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091113-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091113-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091113-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091113-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091113-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091113-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091113-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091113-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091113-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091113-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091113-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091113-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091113-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091113-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091113-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091113-001	AB	1	`8072bd15b7f6…`

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
42043-321-01	2024-12-20	C162847	48780-1	0191ceaa-633c-198a-e063-dbdaa90aec3e	These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004
42043-321-01	2023-07-28	C162847	48780-1	0191ceaa-633c-198a-e063-dbdaa90aec3e	These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42043-321-01	EA - Each	42043-321	12780f57-74fa-4b38-8ac5-3f54a3d21abc	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESZOPICLONE	ACTIVE INGREDIENT	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [ORCHIDPHARMA INC]	1
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [ORCHIDPHARMA INC]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	ESZOPICLONE TABLET, FILM COATED [ORCHIDPHARMA INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESZOPICLONE TABLET, FILM COATED [ORCHIDPHARMA INC]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESZOPICLONE TABLET, FILM COATED [ORCHIDPHARMA INC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESZOPICLONE TABLET, FILM COATED [ORCHIDPHARMA INC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ESZOPICLONE TABLET, FILM COATED [ORCHIDPHARMA INC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	ESZOPICLONE TABLET, FILM COATED [ORCHIDPHARMA INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESZOPICLONE TABLET, FILM COATED [ORCHIDPHARMA INC]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	ESZOPICLONE TABLET, FILM COATED [ORCHIDPHARMA INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESZOPICLONE TABLET, FILM COATED [ORCHIDPHARMA INC]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ESZOPICLONE TABLET, FILM COATED [ORCHIDPHARMA INC]	1

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	Bionpharma Inc.	ec6ac172-509e-403a-aa0d-4c60010a0035	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091113 application number: ANDA091113

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
485442	eszopiclone 2 MG Oral Tablet	PSN	a09a2e9c-dc23-43df-831f-e6c63547d350	102
485442	eszopiclone 2 MG Oral Tablet	SCD	a09a2e9c-dc23-43df-831f-e6c63547d350	102
485442	eszopiclone 2 MG Oral Tablet	PSN	489833bd-1905-63b6-e054-00144ff8d46c	2
485442	eszopiclone 2 MG Oral Tablet	SCD	489833bd-1905-63b6-e054-00144ff8d46c	2
485442	eszopiclone 2 MG Oral Tablet	PSN	29236413-85b8-4c82-be61-0ad66fd9e2c9	1
485442	eszopiclone 2 MG Oral Tablet	SCD	29236413-85b8-4c82-be61-0ad66fd9e2c9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42043-321-01	42043032101	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42043-321-01)	2014-09-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ESZOPICLONE	Bryant Ranch Prepack	2024-05-23	HUMAN PRESCRIPTION DRUG LABEL	102
ESZOPICLONE	OrchidPharma Inc \| Orchid Pharma Ltd \| Orchid Healthcare (A Division of Orchid Pharma Ltd)	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	11
ESZOPICLONE	DIRECT RX	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
ESZOPICLONE	Aidarex Pharmaceuticals LLC	2017-03-02	HUMAN PRESCRIPTION DRUG LABEL	1