ESZOPICLONE

Product NDC
68788-7667
11-digit product format
687887667
Labeler code
68788
Product ID
68788-7667_1fb749c5-2de2-4875-8a41-2eaf6747db82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA208451
Marketing category
ANDA
Marketing start
2020-02-28
Substance
ESZOPICLONE
Active strength
1 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208451-001ESZOPICLONEESZOPICLONE1MGTABLET / ORALAB2016-09-15
A208451-002ESZOPICLONEESZOPICLONE2MGTABLET / ORALAB2016-09-15
A208451-003ESZOPICLONEESZOPICLONE3MGTABLET / ORALAB2016-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208451-001AB
A208451-002AB
A208451-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208451-001ESZOPICLONE1MGTABLET / ORALAB2016-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208451-002ESZOPICLONE2MGTABLET / ORALAB2016-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208451-003ESZOPICLONE3MGTABLET / ORALAB2016-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208451-001ESZOPICLONE1MGTABLET / ORALAB2016-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208451-002ESZOPICLONE2MGTABLET / ORALAB2016-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208451-003ESZOPICLONE3MGTABLET / ORALAB2016-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A208451-001ESZOPICLONE1MGTABLET / ORALAB2016-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208451-002ESZOPICLONE2MGTABLET / ORALAB2016-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208451-003ESZOPICLONE3MGTABLET / ORALAB2016-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208451-001ESZOPICLONE1MGTABLET / ORALAB2016-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208451-002ESZOPICLONE2MGTABLET / ORALAB2016-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208451-003ESZOPICLONE3MGTABLET / ORALAB2016-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208451-001ESZOPICLONE1MGTABLET / ORALAB2016-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208451-002ESZOPICLONE2MGTABLET / ORALAB2016-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208451-003ESZOPICLONE3MGTABLET / ORALAB2016-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208451-001ESZOPICLONE1MGTABLET / ORALAB2016-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208451-002ESZOPICLONE2MGTABLET / ORALAB2016-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208451-003ESZOPICLONE3MGTABLET / ORALAB2016-09-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208451-001ESZOPICLONE1MGTABLET / ORALAB2016-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208451-002ESZOPICLONE2MGTABLET / ORALAB2016-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208451-003ESZOPICLONE3MGTABLET / ORALAB2016-09-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208451-001ESZOPICLONE1MGTABLET / ORALAB2016-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208451-002ESZOPICLONE2MGTABLET / ORALAB2016-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208451-003ESZOPICLONE3MGTABLET / ORALAB2016-09-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208451-001ESZOPICLONE1MGTABLET / ORALAB2016-09-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208451-002ESZOPICLONE2MGTABLET / ORALAB2016-09-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208451-003ESZOPICLONE3MGTABLET / ORALAB2016-09-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208451-001ESZOPICLONE1MGTABLET / ORALAB2016-09-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A208451-002ESZOPICLONE2MGTABLET / ORALAB2016-09-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A208451-003ESZOPICLONE3MGTABLET / ORALAB2016-09-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208451-001ESZOPICLONE1MGTABLET / ORALAB2016-09-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208451-002ESZOPICLONE2MGTABLET / ORALAB2016-09-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208451-003ESZOPICLONE3MGTABLET / ORALAB2016-09-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208451-001ESZOPICLONE1MGTABLET / ORALAB2016-09-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208451-002ESZOPICLONE2MGTABLET / ORALAB2016-09-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208451-003ESZOPICLONE3MGTABLET / ORALAB2016-09-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208451-001ESZOPICLONE1MGTABLET / ORALAB2016-09-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208451-002ESZOPICLONE2MGTABLET / ORALAB2016-09-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208451-003ESZOPICLONE3MGTABLET / ORALAB2016-09-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208451-001ESZOPICLONE1MGTABLET / ORALAB2016-09-158072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208451-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208451-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208451-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208451-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208451-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208451-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208451-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208451-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208451-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208451-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208451-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208451-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208451-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208451-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208451-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208451-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208451-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208451-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208451-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208451-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208451-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208451-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208451-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208451-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208451-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208451-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208451-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208451-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208451-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208451-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208451-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208451-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208451-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208451-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208451-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208451-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208451-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208451-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208451-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208451-001AB18072bd15b7f6…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ESZOPICLONEESZOPICLONEPreferred Pharmaceuticals, Inc.45558f0a-83f1-49b9-ab18-f436c0be96772026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208451
application number: ANDA208451
ndc (product): 68788-7667
ESZOPICLONEESZOPICLONEREMEDYREPACK INC.7df922bc-5750-4259-906f-64f960c38d5f2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208451
application number: ANDA208451
ESZOPICLONEESZOPICLONEA-S Medication Solutions57a8450c-59ee-4c96-bef4-308fa7b97d1e2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208451
application number: ANDA208451
ESZOPICLONEESZOPICLONEA-S Medication Solutionsbfa767ce-340b-4d3a-a9c7-0043b6d7ff6e2025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208451
application number: ANDA208451
ESZOPICLONEESZOPICLONEA-S Medication Solutionse261bf7f-1b89-4393-8c48-4e72fc29192f2025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208451
application number: ANDA208451
ESZOPICLONEESZOPICLONEA-S Medication Solutions923cc646-f22a-4a26-88f7-a19fce0163212025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208451
application number: ANDA208451
ESZOPICLONEESZOPICLONEPD-Rx Pharmaceuticals, Inc.bb972d36-4b2c-45ae-8504-3a16d352dd8b2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208451
application number: ANDA208451
EszopicloneESZOPICLONEAdvanced Rx of Tennessee, LLCaf869866-0a11-1a05-e053-2a95a90acdb82024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208451
application number: ANDA208451
EszopicloneESZOPICLONEAdvanced Rx of Tennessee, LLCaf86fca8-571e-0cac-e053-2a95a90ae4022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208451
application number: ANDA208451
ESZOPICLONEESZOPICLONEBryant Ranch Prepack39b96725-2a01-4d9f-a56d-af7491b3b6012023-11-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208451
application number: ANDA208451
ESZOPICLONEESZOPICLONEProficient Rx LP2f4fa6e8-be82-4fb5-9a11-9ba8f557c0272022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208451
application number: ANDA208451
ESZOPICLONEESZOPICLONEProficient Rx LP024f833e-c20c-46a2-971b-3f2a716b16782022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208451
application number: ANDA208451
ESZOPICLONEESZOPICLONEAurobindo Pharma Limitedf18cc76f-82aa-4ad7-b8ce-5737733ee1042021-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208451
application number: ANDA208451
ESZOPICLONEESZOPICLONEProficient Rx LPbad8fe65-73c1-4542-8050-720af889905a2020-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208451
application number: ANDA208451

Additional Listing Data#

Finished product
Yes
Brand name base
ESZOPICLONE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESZOPICLONE1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
UZX80K71OEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
485440Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
45558f0a-83f1-49b9-ab18-f436c0be9677Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f65008ed-f925-2246-581a-e6a3201df7e4Product name520250107
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7667-0ESZOPICLONE100 in 1 BOTTLETABLET, FILM COATED1007
68788-7667-1ESZOPICLONE10 in 1 BOTTLETABLET, FILM COATED107
68788-7667-2ESZOPICLONE20 in 1 BOTTLETABLET, FILM COATED207
68788-7667-3ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED307
68788-7667-5ESZOPICLONE15 in 1 BOTTLETABLET, FILM COATED157
68788-7667-6ESZOPICLONE60 in 1 BOTTLETABLET, FILM COATED607
68788-7667-7ESZOPICLONE7 in 1 BOTTLETABLET, FILM COATED77
68788-7667-9ESZOPICLONE90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7667-0EA - Each68788-76677636ec67-9db7-4051-ad2d-908e0320dfb612020-05-08
68788-7667-1EA - Each68788-7667d3955f4d-dc78-4d1f-b74f-21e0a73ff56e12020-05-08
68788-7667-2EA - Each68788-7667404924a1-6ea9-48cb-a94e-52b1f33d0e6e12020-05-08
68788-7667-3EA - Each68788-76671f4a6642-4042-417b-a820-a01f7df741f312020-05-08
68788-7667-5EA - Each68788-7667675d597f-82fc-47b0-ba62-2ff559d6b99612020-05-08
68788-7667-6EA - Each68788-7667c42f48cd-7c7f-4352-933c-e9214917925112020-05-08
68788-7667-7EA - Each68788-76671560ef9b-4447-437d-902d-06e87a96a4c612020-05-08
68788-7667-9EA - Each68788-7667545de869-6f5b-4df0-a9af-bf4128511fb012020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7667ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 8 package rows20250504_45558f0a-83f1-49b9-ab18-f436c0be9677.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN45558f0a-83f1-49b9-ab18-f436c0be96777
485440eszopiclone 1 MG Oral TabletSCD45558f0a-83f1-49b9-ab18-f436c0be96777

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7667-068788766700100 TABLET, FILM COATED in 1 BOTTLE (68788-7667-0) 2020-02-280000-00-00NoNoCurrent
68788-7667-16878876670110 TABLET, FILM COATED in 1 BOTTLE (68788-7667-1) 2020-02-280000-00-00NoNoCurrent
68788-7667-26878876670220 TABLET, FILM COATED in 1 BOTTLE (68788-7667-2) 2020-02-280000-00-00NoNoCurrent
68788-7667-36878876670330 TABLET, FILM COATED in 1 BOTTLE (68788-7667-3) 2020-02-280000-00-00NoNoCurrent
68788-7667-56878876670515 TABLET, FILM COATED in 1 BOTTLE (68788-7667-5) 2020-02-280000-00-00NoNoCurrent
68788-7667-66878876670660 TABLET, FILM COATED in 1 BOTTLE (68788-7667-6) 2020-02-280000-00-00NoNoCurrent
68788-7667-7687887667077 TABLET, FILM COATED in 1 BOTTLE (68788-7667-7) 2020-02-280000-00-00NoNoCurrent
68788-7667-96878876670990 TABLET, FILM COATED in 1 BOTTLE (68788-7667-9) 2020-02-280000-00-00NoNoCurrent