Eszopiclone

Product NDC
50436-3384
11-digit product format
504363384
Labeler code
50436
Product ID
50436-3384_ef73dc24-4d37-473c-a242-6269bd7aceec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
OROPHARYNGEAL
Labeler
Unit Dose Services
Application
ANDA091166
Marketing category
ANDA
Marketing start
2014-04-15
Marketing end
0000-00-00
Substance
ESZOPICLONE
Active strength
3 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
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
50436-3384-1Eszopiclone30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3384ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES]3Legacy NDC, 1 package rows20220111_dc8db885-e4ef-4d72-9808-c5b2af258659.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485442eszopiclone 2 MG Oral TabletPSNdc8db885-e4ef-4d72-9808-c5b2af2586593
485465eszopiclone 3 MG Oral TabletPSNdc8db885-e4ef-4d72-9808-c5b2af2586593
485442eszopiclone 2 MG Oral TabletSCDdc8db885-e4ef-4d72-9808-c5b2af2586593
485465eszopiclone 3 MG Oral TabletSCDdc8db885-e4ef-4d72-9808-c5b2af2586593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-3384-15043633840130 TABLET, FILM COATED in 1 BOTTLE (50436-3384-1) 2021-11-010000-00-00NoNoCurrent