ESZOPICLONE

Product NDC
53217-149
11-digit product format
532170149
Labeler code
53217
Product ID
53217-149_eaca04e2-15b7-45a3-9480-1a678ba9c184
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA091113
Marketing category
ANDA
Marketing start
2014-09-25
Marketing end
0000-00-00
Substance
ESZOPICLONE
Active strength
2 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2019-12-31
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
53217-149-30ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-149ESZOPICLONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20170302_29236413-85b8-4c82-be61-0ad66fd9e2c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485442eszopiclone 2 MG Oral TabletPSN29236413-85b8-4c82-be61-0ad66fd9e2c91
485442eszopiclone 2 MG Oral TabletSCD29236413-85b8-4c82-be61-0ad66fd9e2c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-149-305321701493030 in 1 BOTTLEHistorical