ESZOPICLONE

Product NDC
61919-462
11-digit product format
619190462
Labeler code
61919
Product ID
61919-462_9c9402dc-ee1c-6c1f-e053-2995a90adabd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA091153
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
2021-12-31
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
61919-462-302023-01-30C16284748780-1f386c649-b0f0-0266-e053-dadaa90a7c1aESZOPICLONE 3MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-462-30ESZOPICLONE30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-462-30EA - Each61919-462ded46444-ee3b-4055-963e-c6a9ab0e3ec112018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-462ESZOPICLONE TABLET [DIRECT RX]2Legacy NDC, 1 package rows20200121_673b7e99-1cbb-e888-e053-2a91aa0addc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485465eszopiclone 3 MG Oral TabletPSN673b7e99-1cbb-e888-e053-2a91aa0addc12
485465eszopiclone 3 MG Oral TabletSCD673b7e99-1cbb-e888-e053-2a91aa0addc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-462-306191904623030 TABLET in 1 BOTTLE (61919-462-30) 30 tablet2018-03-120000-00-00NoNoCurrent