ESZOPICLONE

Product NDC
61919-395
11-digit product format
619190395
Labeler code
61919
Product ID
61919-395_f213eee7-863a-48ed-e053-2995a90a10f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA202929
Marketing category
ANDA
Marketing start
2018-03-12
Marketing end
0000-00-00
Substance
ESZOPICLONE
Active strength
3 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2024-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-395-302025-01-30C16284748780-12cef2736-86bf-d83d-e063-dadaa90ab31fESZOPICLONE 3MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-395-30ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-395-30EA - Each61919-395b5593ba6-18b3-420f-9a16-535a872d720012018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-395ESZOPICLONE TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 1 package rows20230113_673c665b-488d-1d74-e053-2991aa0a543d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485465eszopiclone 3 MG Oral TabletPSN673c665b-488d-1d74-e053-2991aa0a543d3
485465eszopiclone 3 MG Oral TabletSCD673c665b-488d-1d74-e053-2991aa0a543d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-395-306191903953030 TABLET, FILM COATED in 1 BOTTLE (61919-395-30) 2018-03-120000-00-00NoNoCurrent