ESZOPICLONE

Product NDC
61919-991
11-digit product format
619190991
Labeler code
61919
Product ID
61919-991_d787b2ce-fed8-096b-e053-2a95a90afb3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRX
Application
ANDA091166
Marketing category
ANDA
Marketing start
2015-12-01
Marketing end
0000-00-00
Substance
ESZOPICLONE
Active strength
1 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-991-302025-01-30C16284748780-12cef2736-91db-d83d-e063-dadaa90ab31fESZOPICLONE
61919-991-602025-01-30C16284748780-12cef2736-91db-d83d-e063-dadaa90ab31fESZOPICLONE
61919-991-902025-01-30C16284748780-12cef2736-91db-d83d-e063-dadaa90ab31fESZOPICLONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-991-30ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED304
61919-991-60ESZOPICLONE60 in 1 BOTTLETABLET, FILM COATED604
61919-991-90ESZOPICLONE90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-991-30EA - Each61919-991675a9852-249c-417c-93f0-027fe737775512020-08-06
61919-991-60EA - Each61919-991340ecf7c-99f1-4061-a9ec-b4adab29220e12022-03-09
61919-991-90EA - Each61919-991578e9679-287b-4721-8563-dbbf07422a6e12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-991ESZOPICLONE TABLET, FILM COATED [DIRECTRX]4Legacy NDC, 3 package rows20220209_25eb24c7-0529-6eec-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN25eb24c7-0529-6eec-e054-00144ff8d46c4
485440eszopiclone 1 MG Oral TabletSCD25eb24c7-0529-6eec-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-991-306191909913030 TABLET, FILM COATED in 1 BOTTLE (61919-991-30) 2015-12-010000-00-00NoNoCurrent
61919-991-606191909916060 TABLET, FILM COATED in 1 BOTTLE (61919-991-60) 2015-12-010000-00-00NoNoCurrent
61919-991-906191909919090 TABLET, FILM COATED in 1 BOTTLE (61919-991-90) 2015-12-010000-00-00NoNoCurrent