ESZOPICLONE

Product NDC
50436-0320
11-digit product format
504360320
Labeler code
50436
Product ID
50436-0320_171b21a8-23e9-46d4-a654-212168967e93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA091113
Marketing category
ANDA
Marketing start
2014-09-25
Marketing end
0000-00-00
Substance
ESZOPICLONE
Active strength
1 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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0320-1ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0320ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES]9Legacy NDC, 1 package rows20171108_97990015-be86-4f6d-a1bb-f15c187a8e9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN97990015-be86-4f6d-a1bb-f15c187a8e9f9
485465eszopiclone 3 MG Oral TabletPSN97990015-be86-4f6d-a1bb-f15c187a8e9f9
485440eszopiclone 1 MG Oral TabletSCD97990015-be86-4f6d-a1bb-f15c187a8e9f9
485465eszopiclone 3 MG Oral TabletSCD97990015-be86-4f6d-a1bb-f15c187a8e9f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0320-15043603200130 in 1 BOTTLEHistorical