Eszopiclone

Product NDC
53217-150
11-digit product format
532170150
Labeler code
53217
Product ID
53217-150_da945963-e887-4560-9951-93ec1552cb45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA091166
Marketing category
ANDA
Marketing start
2014-04-15
Marketing end
0000-00-00
Substance
ESZOPICLONE
Active strength
1 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
53217-150-30Eszopiclone30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-150-30EA - Each53217-1508530b41a-b478-493c-af91-9338a18b8caa12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-150ESZOPICLONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20170302_397a8650-84fa-43ef-9006-922a39bc0b1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN397a8650-84fa-43ef-9006-922a39bc0b1d1
485440eszopiclone 1 MG Oral TabletSCD397a8650-84fa-43ef-9006-922a39bc0b1d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-150-305321701503030 in 1 BOTTLEHistorical