Eszopiclone

Product NDC
43353-101
11-digit product format
433530101
Labeler code
43353
Product ID
43353-101_fcdcacb3-f8a2-4cef-beb0-316dc7485002
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA091169
Marketing category
ANDA
Marketing start
2014-05-15
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-101DDiscontinued by firm2026-08-03
excluded packagepackage43353-10143353-101-30DDiscontinued by firm2026-08-03

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
A091169-001ESZOPICLONEESZOPICLONE1MGTABLET / ORALAB2011-05-23
A091169-002ESZOPICLONEESZOPICLONE2MGTABLET / ORALAB2011-05-23
A091169-003ESZOPICLONEESZOPICLONE3MGTABLET / ORALAB2011-05-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091169-001AB
A091169-002AB
A091169-003AB

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 UTC2026-02A091169-001ESZOPICLONE1MGTABLET / ORALAB2011-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091169-002ESZOPICLONE2MGTABLET / ORALAB2011-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091169-003ESZOPICLONE3MGTABLET / ORALAB2011-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091169-001ESZOPICLONE1MGTABLET / ORALAB2011-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091169-002ESZOPICLONE2MGTABLET / ORALAB2011-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091169-003ESZOPICLONE3MGTABLET / ORALAB2011-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A091169-001ESZOPICLONE1MGTABLET / ORALAB2011-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091169-002ESZOPICLONE2MGTABLET / ORALAB2011-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091169-003ESZOPICLONE3MGTABLET / ORALAB2011-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091169-001ESZOPICLONE1MGTABLET / ORALAB2011-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091169-002ESZOPICLONE2MGTABLET / ORALAB2011-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091169-003ESZOPICLONE3MGTABLET / ORALAB2011-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091169-001ESZOPICLONE1MGTABLET / ORALAB2011-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091169-002ESZOPICLONE2MGTABLET / ORALAB2011-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091169-003ESZOPICLONE3MGTABLET / ORALAB2011-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091169-001ESZOPICLONE1MGTABLET / ORALAB2011-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091169-002ESZOPICLONE2MGTABLET / ORALAB2011-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091169-003ESZOPICLONE3MGTABLET / ORALAB2011-05-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091169-001ESZOPICLONE1MGTABLET / ORALAB2011-05-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091169-002ESZOPICLONE2MGTABLET / ORALAB2011-05-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091169-003ESZOPICLONE3MGTABLET / ORALAB2011-05-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091169-001ESZOPICLONE1MGTABLET / ORALAB2011-05-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091169-002ESZOPICLONE2MGTABLET / ORALAB2011-05-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091169-003ESZOPICLONE3MGTABLET / ORALAB2011-05-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091169-001ESZOPICLONE1MGTABLET / ORALAB2011-05-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091169-002ESZOPICLONE2MGTABLET / ORALAB2011-05-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091169-003ESZOPICLONE3MGTABLET / ORALAB2011-05-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091169-001ESZOPICLONE1MGTABLET / ORALAB2011-05-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A091169-002ESZOPICLONE2MGTABLET / ORALAB2011-05-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A091169-003ESZOPICLONE3MGTABLET / ORALAB2011-05-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091169-001ESZOPICLONE1MGTABLET / ORALAB2011-05-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091169-002ESZOPICLONE2MGTABLET / ORALAB2011-05-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091169-003ESZOPICLONE3MGTABLET / ORALAB2011-05-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091169-001ESZOPICLONE1MGTABLET / ORALAB2011-05-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091169-002ESZOPICLONE2MGTABLET / ORALAB2011-05-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091169-003ESZOPICLONE3MGTABLET / ORALAB2011-05-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091169-001ESZOPICLONE1MGTABLET / ORALAB2011-05-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091169-002ESZOPICLONE2MGTABLET / ORALAB2011-05-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091169-003ESZOPICLONE3MGTABLET / ORALAB2011-05-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091169-001ESZOPICLONE1MGTABLET / ORALAB2011-05-238072bd15b7f6…

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 UTC2026-02A091169-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091169-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091169-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091169-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091169-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091169-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091169-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091169-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091169-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091169-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091169-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091169-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091169-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091169-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091169-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091169-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091169-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091169-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091169-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091169-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091169-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091169-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091169-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091169-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091169-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091169-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091169-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091169-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091169-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091169-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091169-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091169-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091169-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091169-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091169-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091169-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091169-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091169-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091169-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091169-001AB18072bd15b7f6…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EszopicloneESZOPICLONETeva Pharmaceuticals USA, Inc.2435e2f1-bc52-488f-80e9-f1758e354aae2021-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091169
application number: ANDA091169
EszopicloneESZOPICLONEAphena Pharma Solutions - Tennessee, LLC9bbf260f-3090-46b5-b3ef-81174697f1662020-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091169
application number: ANDA091169

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-101-30EA - Each43353-1018a2a7c1a-70f3-4a42-ab33-2e04f620b01212016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-101ESZOPICLONE (ESZOPICLONE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20160617_f8321fa5-1ed7-4e48-bf54-4c86e3e868b3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-101-304335301013030 TABLET, FILM COATED in 1 BOTTLE (43353-101-30) 2015-09-050000-00-00NoNoCurrent