Eszopiclone

Product NDC
43353-185
11-digit product format
433530185
Labeler code
43353
Product ID
43353-185_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
3 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-185-30Eszopiclone30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-185-30EA - Each43353-185fdb78b0e-bb54-443e-8f21-2fd4e136f92112016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-185ESZOPICLONE 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
43353-185-304335301853030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-185-30) 2016-06-100000-00-00NoNoCurrent