FDA.reportPublic FDA data

ESZOPICLONE

Product NDC
50436-0322
11-digit product format
504360322
Labeler code
50436
Product ID
50436-0322_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
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-0322-12021-01-29C16284748780-1ba0f9c33-5582-a910-e053-dadaa90a0b85These 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
50436-0322-42021-01-29C16284748780-1ba0f9c33-5582-a910-e053-dadaa90a0b85These 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
50436-0322-1ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED309
50436-0322-4ESZOPICLONE100 in 1 BOTTLETABLET, FILM COATED1009

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
50436-0322-15043603220130 in 1 BOTTLEHistorical
50436-0322-450436032204100 in 1 BOTTLEHistorical