Eszopiclone

Product NDC
50436-0301
11-digit product format
504360301
Labeler code
50436
Product ID
50436-0301_8fc6797c-64d4-4344-8911-8f89f9130d8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA202929
Marketing category
ANDA
Marketing start
2014-04-25
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0301-1Eszopiclone30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0301-1EA - Each50436-030192174a9c-6a07-40c5-898a-f29ce52080f712017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0301ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES]7Legacy NDC, 1 package rows20171109_08a9069d-c914-48c8-a2cc-353965398f2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN08a9069d-c914-48c8-a2cc-353965398f2c7
485442eszopiclone 2 MG Oral TabletPSN08a9069d-c914-48c8-a2cc-353965398f2c7
485465eszopiclone 3 MG Oral TabletPSN08a9069d-c914-48c8-a2cc-353965398f2c7
485440eszopiclone 1 MG Oral TabletSCD08a9069d-c914-48c8-a2cc-353965398f2c7
485442eszopiclone 2 MG Oral TabletSCD08a9069d-c914-48c8-a2cc-353965398f2c7
485465eszopiclone 3 MG Oral TabletSCD08a9069d-c914-48c8-a2cc-353965398f2c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0301-15043603010130 in 1 BOTTLEHistorical