Eszopiclone

Product NDC
76420-026
11-digit product format
764200026
Labeler code
76420
Product ID
76420-026_2df4e9b7-6d0c-7409-e063-6294a90a46ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA202929
Marketing category
ANDA
Marketing start
2015-01-31
Substance
ESZOPICLONE
Active strength
1 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
A202929-001ESZOPICLONEESZOPICLONE1MGTABLET / ORALAB2015-01-30
A202929-002ESZOPICLONEESZOPICLONE2MGTABLET / ORALAB2015-01-30
A202929-003ESZOPICLONEESZOPICLONE3MGTABLET / ORALAB2015-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202929-001AB
A202929-002AB
A202929-003AB

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 UTC2026-02A202929-001ESZOPICLONE1MGTABLET / ORALAB2015-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202929-002ESZOPICLONE2MGTABLET / ORALAB2015-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202929-003ESZOPICLONE3MGTABLET / ORALAB2015-01-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202929-001ESZOPICLONE1MGTABLET / ORALAB2015-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202929-002ESZOPICLONE2MGTABLET / ORALAB2015-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202929-003ESZOPICLONE3MGTABLET / ORALAB2015-01-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202929-001ESZOPICLONE1MGTABLET / ORALAB2015-01-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202929-002ESZOPICLONE2MGTABLET / ORALAB2015-01-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202929-003ESZOPICLONE3MGTABLET / ORALAB2015-01-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202929-001ESZOPICLONE1MGTABLET / ORALAB2015-01-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202929-002ESZOPICLONE2MGTABLET / ORALAB2015-01-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202929-003ESZOPICLONE3MGTABLET / ORALAB2015-01-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202929-001ESZOPICLONE1MGTABLET / ORALAB2015-01-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202929-002ESZOPICLONE2MGTABLET / ORALAB2015-01-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202929-003ESZOPICLONE3MGTABLET / ORALAB2015-01-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202929-001ESZOPICLONE1MGTABLET / ORALAB2015-01-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202929-002ESZOPICLONE2MGTABLET / ORALAB2015-01-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202929-003ESZOPICLONE3MGTABLET / ORALAB2015-01-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202929-001ESZOPICLONE1MGTABLET / ORALAB2015-01-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202929-002ESZOPICLONE2MGTABLET / ORALAB2015-01-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202929-003ESZOPICLONE3MGTABLET / ORALAB2015-01-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202929-001ESZOPICLONE1MGTABLET / ORALAB2015-01-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202929-002ESZOPICLONE2MGTABLET / ORALAB2015-01-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202929-003ESZOPICLONE3MGTABLET / ORALAB2015-01-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202929-001ESZOPICLONE1MGTABLET / ORALAB2015-01-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202929-002ESZOPICLONE2MGTABLET / ORALAB2015-01-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202929-003ESZOPICLONE3MGTABLET / ORALAB2015-01-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202929-001ESZOPICLONE1MGTABLET / ORALAB2015-01-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A202929-002ESZOPICLONE2MGTABLET / ORALAB2015-01-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A202929-003ESZOPICLONE3MGTABLET / ORALAB2015-01-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202929-001ESZOPICLONE1MGTABLET / ORALAB2015-01-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202929-002ESZOPICLONE2MGTABLET / ORALAB2015-01-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202929-003ESZOPICLONE3MGTABLET / ORALAB2015-01-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202929-001ESZOPICLONE1MGTABLET / ORALAB2015-01-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202929-002ESZOPICLONE2MGTABLET / ORALAB2015-01-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202929-003ESZOPICLONE3MGTABLET / ORALAB2015-01-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202929-001ESZOPICLONE1MGTABLET / ORALAB2015-01-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202929-002ESZOPICLONE2MGTABLET / ORALAB2015-01-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202929-003ESZOPICLONE3MGTABLET / ORALAB2015-01-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202929-001ESZOPICLONE1MGTABLET / ORALAB2015-01-308072bd15b7f6…

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 UTC2026-02A202929-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202929-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202929-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202929-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202929-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202929-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202929-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202929-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202929-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202929-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202929-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202929-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202929-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202929-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202929-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202929-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202929-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202929-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202929-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202929-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202929-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202929-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202929-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202929-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202929-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202929-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202929-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202929-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202929-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202929-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202929-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202929-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202929-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202929-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202929-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202929-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202929-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202929-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202929-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202929-001AB18072bd15b7f6…

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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EszopicloneESZOPICLONEPreferred Pharmaceuticals Inc.2b5b4fbb-9b86-46c6-9508-37d3d9806dec2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
EszopicloneESZOPICLONEREMEDYREPACK INC.61fd4655-060f-4393-a610-019d8b1270582026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
EszopicloneESZOPICLONEPreferred Pharmaceuticals Inc.abe3a610-a25d-4b52-8537-c87e8ba3104a2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
ESZOPICLONEESZOPICLONEDIRECT RX486b760b-7fea-306b-e054-00144ff8d46c2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
EszopicloneESZOPICLONEBryant Ranch Prepackf6022b2f-9b43-40cc-91c7-c224b209efab2025-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
EszopicloneESZOPICLONEREMEDYREPACK INC.9dfe774a-2c7a-4e10-bedd-cde64ad286762025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
EszopicloneESZOPICLONEAsclemed USA, Inc.10175591-c1b4-461a-830e-8df982d0d2bf2025-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
ndc (product): 76420-026
EszopicloneESZOPICLONEPreferred Pharmaceuticals Inc.be25bb4e-d84f-4396-a78f-a668a207cf2d2025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
EszopicloneESZOPICLONEAdvanced Rx of Tennessee, LLCaf86fca8-571a-0cac-e053-2a95a90ae4022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
EszopicloneESZOPICLONEAdvanced Rx of Tennessee, LLCaf863d89-25db-2893-e053-2a95a90a704c2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
EszopicloneESZOPICLONEAdvanced Rx Pharmacy of Tennessee, LLCc8ae09eb-4c9b-4560-e053-2995a90a02b12024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
EszopicloneESZOPICLONELake Erie Medical DBA Quality Care Products LLC9460be93-cd53-4429-a4d9-2f04e38351682024-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
EszopicloneESZOPICLONEQuality Care Products LLC3b8a09c6-0702-43a7-b47f-a36cd00b75842024-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
EszopicloneESZOPICLONEQuality Care Products LLC7832f554-2b82-4ef2-b1ef-266179f271d32024-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
EszopicloneESZOPICLONEBryant Ranch Prepack9a891ab1-675f-498e-a21e-05964307d2dd2024-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
EszopicloneESZOPICLONENuCarePharmaceuticals, Inc.53fcee89-027a-13e5-e054-00144ff8d46c2024-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
EszopicloneESZOPICLONEProficient Rx LPd301b0cf-1492-4be9-83a0-1b64c8fa3b722023-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
EszopicloneESZOPICLONEMacleods Pharmaceuticals Limited12593790-e72f-45b1-8895-987cdd0751342022-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
EszopicloneESZOPICLONEProficient Rx LP5451be60-1315-4152-ad13-412e86903c8a2022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929
EszopicloneESZOPICLONEProficient Rx LP1582ba77-a4e3-464f-876b-28cc7e41e8f12020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202929
application number: ANDA202929

Additional Listing Data#

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

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 · 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
10175591-c1b4-461a-830e-8df982d0d2bfAvailable 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
76420-026-01Eszopiclone100 in 1 BOTTLETABLET, FILM COATED1002
76420-026-10Eszopiclone10 in 1 BOTTLETABLET, FILM COATED102
76420-026-20Eszopiclone20 in 1 BOTTLETABLET, FILM COATED202
76420-026-30Eszopiclone30 in 1 BOTTLETABLET, FILM COATED302
76420-026-60Eszopiclone60 in 1 BOTTLETABLET, FILM COATED602
76420-026-90Eszopiclone90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-026-01EA - Each76420-026d8e74b26-0439-45f2-8a12-ad69dec4561212022-08-04
76420-026-10EA - Each76420-0261185154d-0764-4901-b34d-3dc47898ed3912022-08-04
76420-026-20EA - Each76420-0268930668f-13e7-4446-9241-f491faf7205c12022-08-04
76420-026-30EA - Each76420-026c8cae2cf-1f93-4dbc-b2f6-7c141721984412022-08-04
76420-026-60EA - Each76420-0266313d5d7-527f-4a74-8c32-e94c1b53011b12022-08-04
76420-026-90EA - Each76420-026b90df05a-d210-44be-9868-a7dfecddfc8912022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-026ESZOPICLONE TABLET, FILM COATED [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 6 package rows20250214_10175591-c1b4-461a-830e-8df982d0d2bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN10175591-c1b4-461a-830e-8df982d0d2bf2
485442eszopiclone 2 MG Oral TabletPSN10175591-c1b4-461a-830e-8df982d0d2bf2
485465eszopiclone 3 MG Oral TabletPSN10175591-c1b4-461a-830e-8df982d0d2bf2
485440eszopiclone 1 MG Oral TabletSCD10175591-c1b4-461a-830e-8df982d0d2bf2
485442eszopiclone 2 MG Oral TabletSCD10175591-c1b4-461a-830e-8df982d0d2bf2
485465eszopiclone 3 MG Oral TabletSCD10175591-c1b4-461a-830e-8df982d0d2bf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-026-0176420002601100 TABLET, FILM COATED in 1 BOTTLE (76420-026-01) 2020-06-170000-00-00NoNoCurrent
76420-026-107642000261010 TABLET, FILM COATED in 1 BOTTLE (76420-026-10) 2020-06-170000-00-00NoNoCurrent
76420-026-207642000262020 TABLET, FILM COATED in 1 BOTTLE (76420-026-20) 2020-06-170000-00-00NoNoCurrent
76420-026-307642000263030 TABLET, FILM COATED in 1 BOTTLE (76420-026-30) 2020-06-170000-00-00NoNoCurrent
76420-026-607642000266060 TABLET, FILM COATED in 1 BOTTLE (76420-026-60) 2020-06-170000-00-00NoNoCurrent
76420-026-907642000269090 TABLET, FILM COATED in 1 BOTTLE (76420-026-90) 2020-06-170000-00-00NoNoCurrent