FDA.reportPublic FDA data

Eszopiclone

Product NDC
43353-200
11-digit product format
433530200
Labeler code
43353
Product ID
43353-200_6b3fcf8b-dc69-41da-9e59-9cb9eaf03acd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA091151
Marketing category
ANDA
Marketing start
2016-01-19
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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-200-302023-01-30C16284748780-1f386c64a-1610-0266-e053-dadaa90a7c1aThese 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
43353-200-30Eszopiclone30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-200-30EA - Each43353-2009393c377-9b13-4b44-a25c-9f456ed91c8e12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-200ESZOPICLONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Legacy NDC, 1 package rows20191228_eb967d20-9a6d-4ccd-8618-22b87faa1d84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485442eszopiclone 2 MG Oral TabletPSNeb967d20-9a6d-4ccd-8618-22b87faa1d844
485465eszopiclone 3 MG Oral TabletPSNeb967d20-9a6d-4ccd-8618-22b87faa1d844
485442eszopiclone 2 MG Oral TabletSCDeb967d20-9a6d-4ccd-8618-22b87faa1d844
485465eszopiclone 3 MG Oral TabletSCDeb967d20-9a6d-4ccd-8618-22b87faa1d844

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-200-304335302003030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-200-30) 2016-06-240000-00-00NoNoCurrent