ESZOPICLONE

Product NDC
61919-119
11-digit product format
619190119
Labeler code
61919
Product ID
61919-119_ab1d6b86-1301-56cd-e053-2995a90a5af1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA202929
Marketing category
ANDA
Marketing start
2017-03-29
Marketing end
0000-00-00
Substance
ESZOPICLONE
Active strength
1 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-119-30ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED304
61919-119-60ESZOPICLONE60 in 1 BOTTLETABLET, FILM COATED604
61919-119-90ESZOPICLONE90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-119-30EA - Each61919-11965b8dfb4-a7a8-44d1-8285-2f583c2b03de12018-09-05
61919-119-60EA - Each61919-11940e068c5-a198-4cf5-94a1-df1b0fa6360612023-08-08
61919-119-90EA - Each61919-119b6e0d723-add6-4782-8b99-e1a8e3b86c6812019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-119ESZOPICLONE TABLET, FILM COATED [DIRECT RX]4Legacy NDC, 2 package rows20230707_4be28e4b-6cc4-6b26-e054-00144ff8d46c.zip
61919-119ESZOPICLONE TABLET, FILM COATED [DIRECT_RX]2Legacy NDC, 1 package rows20200121_8fb1ca25-f1db-11bd-e053-2a95a90a8ab7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN4be28e4b-6cc4-6b26-e054-00144ff8d46c4
485440eszopiclone 1 MG Oral TabletSCD4be28e4b-6cc4-6b26-e054-00144ff8d46c4
485440eszopiclone 1 MG Oral TabletPSN8fb1ca25-f1db-11bd-e053-2a95a90a8ab72
485440eszopiclone 1 MG Oral TabletSCD8fb1ca25-f1db-11bd-e053-2a95a90a8ab72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-119-306191901193030 TABLET, FILM COATED in 1 BOTTLE (61919-119-30) 2017-03-290000-00-00NoNoCurrent
61919-119-606191901196060 in 1 BOTTLEHistorical
61919-119-906191901199090 TABLET, FILM COATED in 1 BOTTLE (61919-119-90) 2019-08-090000-00-00NoNoCurrent