FDA.reportPublic FDA data

ESZOPICLONE

Product NDC
71335-1794
11-digit product format
713351794
Labeler code
71335
Product ID
71335-1794_2fd7fa6e-bb39-410b-8676-91ff34c2ce1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091113
Marketing category
ANDA
Marketing start
2014-09-25
Marketing end
0000-00-00
Substance
ESZOPICLONE
Active strength
3 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1794-12024-01-30C16284748780-11030e365-56a5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004
71335-1794-22024-01-30C16284748780-11030e365-56a5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004
71335-1794-32024-01-30C16284748780-11030e365-56a5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004
71335-1794-42024-01-30C16284748780-11030e365-56a5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004
71335-1794-52024-01-30C16284748780-11030e365-56a5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004
71335-1794-62024-01-30C16284748780-11030e365-56a5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004
71335-1794-72024-01-30C16284748780-11030e365-56a5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004
71335-1794-82024-01-30C16284748780-11030e365-56a5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1794-1ESZOPICLONE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED30102
71335-1794-2ESZOPICLONE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED60102
71335-1794-3ESZOPICLONE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED90102
71335-1794-4ESZOPICLONE120 in 1 BOTTLE, PLASTICTABLET, FILM COATED120102
71335-1794-5ESZOPICLONE20 in 1 BOTTLE, PLASTICTABLET, FILM COATED20102
71335-1794-6ESZOPICLONE28 in 1 BOTTLE, PLASTICTABLET, FILM COATED28102
71335-1794-7ESZOPICLONE15 in 1 BOTTLE, PLASTICTABLET, FILM COATED15102
71335-1794-8ESZOPICLONE100 in 1 BOTTLE, PLASTICTABLET, FILM COATED100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1794-1EA - Each71335-17943a2b4a78-0e20-48d4-a71b-90d11f87ae2912021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1794ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Legacy NDC, 8 package rows20220226_2fd7fa6e-bb39-410b-8676-91ff34c2ce1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485465eszopiclone 3 MG Oral TabletPSN2fd7fa6e-bb39-410b-8676-91ff34c2ce1e102
485465eszopiclone 3 MG Oral TabletSCD2fd7fa6e-bb39-410b-8676-91ff34c2ce1e102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1794-17133517940130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1794-1) 2021-03-090000-00-00NoNoCurrent
71335-1794-27133517940260 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1794-2) 2021-03-100000-00-00NoNoCurrent
71335-1794-37133517940390 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1794-3) 2021-03-100000-00-00NoNoCurrent
71335-1794-471335179404120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1794-4) 2021-03-100000-00-00NoNoCurrent
71335-1794-57133517940520 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1794-5) 2022-02-140000-00-00NoNoCurrent
71335-1794-67133517940628 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1794-6) 2022-02-140000-00-00NoNoCurrent
71335-1794-77133517940715 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1794-7) 2022-02-140000-00-00NoNoCurrent
71335-1794-871335179408100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1794-8) 2022-02-140000-00-00NoNoCurrent