Eszopiclone

Product NDC
68180-324
11-digit product format
681800324
Labeler code
68180
Product ID
68180-324_a3530781-6fea-425f-9958-eeb2d0b3c696
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA091124
Marketing category
ANDA
Marketing start
2014-04-15
Substance
ESZOPICLONE
Active strength
3 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
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
A091124-001ESZOPICLONEESZOPICLONE1MGTABLET / ORAL2011-09-13
A091124-002ESZOPICLONEESZOPICLONE2MGTABLET / ORAL2011-09-13
A091124-003ESZOPICLONEESZOPICLONE3MGTABLET / ORAL2011-09-13

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 UTC2026-02A091124-001ESZOPICLONE1MGTABLET / ORALAB2011-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091124-002ESZOPICLONE2MGTABLET / ORALAB2011-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091124-003ESZOPICLONE3MGTABLET / ORALAB2011-09-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091124-001ESZOPICLONE1MGTABLET / ORALAB2011-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091124-002ESZOPICLONE2MGTABLET / ORALAB2011-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091124-003ESZOPICLONE3MGTABLET / ORALAB2011-09-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A091124-001ESZOPICLONE1MGTABLET / ORALAB2011-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091124-002ESZOPICLONE2MGTABLET / ORALAB2011-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091124-003ESZOPICLONE3MGTABLET / ORALAB2011-09-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091124-001ESZOPICLONE1MGTABLET / ORALAB2011-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091124-002ESZOPICLONE2MGTABLET / ORALAB2011-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091124-003ESZOPICLONE3MGTABLET / ORALAB2011-09-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091124-001ESZOPICLONE1MGTABLET / ORALAB2011-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091124-002ESZOPICLONE2MGTABLET / ORALAB2011-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091124-003ESZOPICLONE3MGTABLET / ORALAB2011-09-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091124-001ESZOPICLONE1MGTABLET / ORALAB2011-09-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091124-002ESZOPICLONE2MGTABLET / ORALAB2011-09-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091124-003ESZOPICLONE3MGTABLET / ORALAB2011-09-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091124-001ESZOPICLONE1MGTABLET / ORALAB2011-09-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091124-002ESZOPICLONE2MGTABLET / ORALAB2011-09-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091124-003ESZOPICLONE3MGTABLET / ORALAB2011-09-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091124-001ESZOPICLONE1MGTABLET / ORALAB2011-09-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091124-002ESZOPICLONE2MGTABLET / ORALAB2011-09-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091124-003ESZOPICLONE3MGTABLET / ORALAB2011-09-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091124-001ESZOPICLONE1MGTABLET / ORALAB2011-09-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091124-002ESZOPICLONE2MGTABLET / ORALAB2011-09-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091124-003ESZOPICLONE3MGTABLET / ORALAB2011-09-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091124-001ESZOPICLONE1MGTABLET / ORALAB2011-09-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A091124-002ESZOPICLONE2MGTABLET / ORALAB2011-09-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A091124-003ESZOPICLONE3MGTABLET / ORALAB2011-09-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091124-001ESZOPICLONE1MGTABLET / ORALAB2011-09-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091124-002ESZOPICLONE2MGTABLET / ORALAB2011-09-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091124-003ESZOPICLONE3MGTABLET / ORALAB2011-09-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091124-001ESZOPICLONE1MGTABLET / ORALAB2011-09-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091124-002ESZOPICLONE2MGTABLET / ORALAB2011-09-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091124-003ESZOPICLONE3MGTABLET / ORALAB2011-09-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091124-001ESZOPICLONE1MGTABLET / ORALAB2011-09-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091124-002ESZOPICLONE2MGTABLET / ORALAB2011-09-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091124-003ESZOPICLONE3MGTABLET / ORALAB2011-09-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091124-001ESZOPICLONE1MGTABLET / ORALAB2011-09-138072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091124-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091124-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091124-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091124-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091124-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091124-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091124-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091124-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091124-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091124-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091124-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091124-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091124-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091124-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091124-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091124-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091124-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091124-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091124-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091124-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091124-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091124-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091124-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091124-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091124-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091124-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091124-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091124-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091124-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091124-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091124-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091124-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091124-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091124-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091124-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091124-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091124-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091124-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091124-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091124-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Eszopiclone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESZOPICLONE3 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
485440Internal RxNorm lookup
485442Internal RxNorm lookup
485465Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7068c455-691e-4c56-9857-b7b4e13f4784Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f65008ed-f925-2246-581a-e6a3201df7e4Product name520250107

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-324-01Eszopiclone100 in 1 BOTTLETABLET, FILM COATED10015
68180-324-02Eszopiclone500 in 1 BOTTLETABLET, FILM COATED50015
68180-324-03Eszopiclone1000 in 1 BOTTLETABLET, FILM COATED100015
68180-324-11Eszopiclone14 in 1 BLISTER PACKTABLET, FILM COATED1415

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-324-01EA - Each68180-3243c42f0e7-2438-4b72-820f-2fae40f2de4e12014-05-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-324ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 4 package rows20240118_7068c455-691e-4c56-9857-b7b4e13f4784.zip

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EszopicloneESZOPICLONEPD-Rx Pharmaceuticals, Inc.4832cfbf-a540-46af-bb7d-3ba8e6bc783e2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091124
application number: ANDA091124
ESZOPICLONEESZOPICLONEDIRECT RXa7bd3e3c-26e9-07e7-e053-2995a90a9ca52025-01-17Boxed warning, Adverse reactionsExact identifier
application applno (ANDA): 091124
application number: ANDA091124
EszopicloneESZOPICLONEAdvanced Rx of Tennessee, LLCb39dc64d-adc9-742e-e053-2a95a90ad18b2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091124
application number: ANDA091124
EszopicloneESZOPICLONEAdvanced Rx Pharmacy of Tennessee, LLCb4f272eb-02e3-415a-e053-2a95a90a428f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091124
application number: ANDA091124
EszopicloneESZOPICLONELupin Pharmaceuticals, Inc.7068c455-691e-4c56-9857-b7b4e13f47842024-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091124
application number: ANDA091124
ndc (product): 68180-324

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN7068c455-691e-4c56-9857-b7b4e13f478415
485442eszopiclone 2 MG Oral TabletPSN7068c455-691e-4c56-9857-b7b4e13f478415
485465eszopiclone 3 MG Oral TabletPSN7068c455-691e-4c56-9857-b7b4e13f478415
485440eszopiclone 1 MG Oral TabletSCD7068c455-691e-4c56-9857-b7b4e13f478415
485442eszopiclone 2 MG Oral TabletSCD7068c455-691e-4c56-9857-b7b4e13f478415
485465eszopiclone 3 MG Oral TabletSCD7068c455-691e-4c56-9857-b7b4e13f478415
485465eszopiclone 3 MG Oral TabletPSN4832cfbf-a540-46af-bb7d-3ba8e6bc783e14
485465eszopiclone 3 MG Oral TabletSCD4832cfbf-a540-46af-bb7d-3ba8e6bc783e14
485465eszopiclone 3 MG Oral TabletPSNb4f272eb-02e3-415a-e053-2a95a90a428f6
485465eszopiclone 3 MG Oral TabletSCDb4f272eb-02e3-415a-e053-2a95a90a428f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-324-0168180032401100 TABLET, FILM COATED in 1 BOTTLE (68180-324-01) 2014-04-150000-00-00NoNoCurrent
68180-324-0268180032402500 TABLET, FILM COATED in 1 BOTTLE (68180-324-02) 2014-04-150000-00-00NoNoCurrent
68180-324-03681800324031000 TABLET, FILM COATED in 1 BOTTLE (68180-324-03) 2014-04-150000-00-00NoNoCurrent
68180-324-116818003241114 in 1 BLISTER PACKHistorical
68180-324-13681800324137 BLISTER PACK in 1 CARTON (68180-324-13) > 14 TABLET, FILM COATED in 1 BLISTER PACK (68180-324-11) 7 blister pack2014-04-150000-00-00NoNoCurrent