Eszopiclone

Product NDC
71335-0089
11-digit product format
713350089
Labeler code
71335
Product ID
71335-0089_1cede81a-b1b6-4a31-bba8-9f7d483d2292
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202929
Marketing category
ANDA
Marketing start
2015-01-31
Substance
ESZOPICLONE
Active strength
2 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#

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 · 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
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
ndc (product): 71335-0089
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
ESZOPICLONE2 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
9a891ab1-675f-498e-a21e-05964307d2ddAvailable 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
71335-0089-1Eszopiclone30 in 1 BOTTLETABLET, FILM COATED3021
71335-0089-2Eszopiclone60 in 1 BOTTLETABLET, FILM COATED6021
71335-0089-3Eszopiclone90 in 1 BOTTLETABLET, FILM COATED9021
71335-0089-4Eszopiclone120 in 1 BOTTLETABLET, FILM COATED12021
71335-0089-5Eszopiclone20 in 1 BOTTLETABLET, FILM COATED2021
71335-0089-6Eszopiclone100 in 1 BOTTLETABLET, FILM COATED10021
71335-0089-7Eszopiclone28 in 1 BOTTLETABLET, FILM COATED2821
71335-0089-8Eszopiclone10 in 1 BOTTLETABLET, FILM COATED1021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0089-1EA - Each71335-00895d992b52-f53e-4374-8550-5fd806456afc12018-05-09
71335-0089-2EA - Each71335-0089b2b3b279-469e-4c74-8201-be1729b3ec4312018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0089ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]21Current NDC, Legacy NDC, 8 package rows20240809_9a891ab1-675f-498e-a21e-05964307d2dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN9a891ab1-675f-498e-a21e-05964307d2dd21
485442eszopiclone 2 MG Oral TabletPSN9a891ab1-675f-498e-a21e-05964307d2dd21
485465eszopiclone 3 MG Oral TabletPSN9a891ab1-675f-498e-a21e-05964307d2dd21
485440eszopiclone 1 MG Oral TabletSCD9a891ab1-675f-498e-a21e-05964307d2dd21
485442eszopiclone 2 MG Oral TabletSCD9a891ab1-675f-498e-a21e-05964307d2dd21
485465eszopiclone 3 MG Oral TabletSCD9a891ab1-675f-498e-a21e-05964307d2dd21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0089-17133500890130 TABLET, FILM COATED in 1 BOTTLE (71335-0089-1) 2017-02-070000-00-00NoNoCurrent
71335-0089-27133500890260 TABLET, FILM COATED in 1 BOTTLE (71335-0089-2) 2017-02-070000-00-00NoNoCurrent
71335-0089-37133500890390 TABLET, FILM COATED in 1 BOTTLE (71335-0089-3) 2017-02-070000-00-00NoNoCurrent
71335-0089-471335008904120 TABLET, FILM COATED in 1 BOTTLE (71335-0089-4) 2017-02-070000-00-00NoNoCurrent
71335-0089-57133500890520 TABLET, FILM COATED in 1 BOTTLE (71335-0089-5) 2017-02-070000-00-00NoNoCurrent
71335-0089-671335008906100 TABLET, FILM COATED in 1 BOTTLE (71335-0089-6) 2017-02-070000-00-00NoNoCurrent
71335-0089-77133500890728 TABLET, FILM COATED in 1 BOTTLE (71335-0089-7) 2017-02-070000-00-00NoNoCurrent
71335-0089-87133500890810 TABLET, FILM COATED in 1 BOTTLE (71335-0089-8) 2017-02-070000-00-00NoNoCurrent