ESZOPICLONE

Product NDC
61919-514
11-digit product format
619190514
Labeler code
61919
Product ID
61919-514_9c940e14-e15a-1bba-e053-2a95a90a5599
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA091113
Marketing category
ANDA
Marketing start
2015-12-15
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-514-302023-01-30C16284748780-1f386c64a-3c83-0266-e053-dadaa90a7c1aESZOPICLONE 3mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-514-30ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-514-30EA - Each61919-514a6ea3a09-7c6e-4390-a24a-bd2f21f028f512016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-514ESZOPICLONE TABLET, FILM COATED [DIRECT RX]2Legacy NDC, 1 package rows20200131_2cedcc9d-ab83-3b5a-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485465eszopiclone 3 MG Oral TabletPSN2cedcc9d-ab83-3b5a-e054-00144ff8d46c2
485465eszopiclone 3 MG Oral TabletSCD2cedcc9d-ab83-3b5a-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-514-306191905143030 TABLET, FILM COATED in 1 BOTTLE (61919-514-30) 2015-12-150000-00-00NoNoCurrent