Eszopiclone

Product NDC
43353-097
11-digit product format
433530097
Labeler code
43353
Product ID
43353-097_fcdcacb3-f8a2-4cef-beb0-316dc7485002
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA091169
Marketing category
ANDA
Marketing start
2014-05-15
Marketing end
0000-00-00
Substance
ESZOPICLONE
Active strength
3 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-097-30EA - Each43353-09795caef44-7485-45f7-b403-b99c86451f1e12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-097ESZOPICLONE (ESZOPICLONE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20160617_f8321fa5-1ed7-4e48-bf54-4c86e3e868b3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-097-304335300973030 TABLET, FILM COATED in 1 BOTTLE (43353-097-30) 2015-08-300000-00-00NoNoCurrent