Sertraline Hydrochloride

Product NDC
43353-970
11-digit product format
433530970
Labeler code
43353
Product ID
43353-970_1e0a30cf-a624-4b41-aa91-c6fde1419cdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077397
Marketing category
ANDA
Marketing start
2007-10-18
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-970SERTRALINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20160707_37d03cf5-3011-40fe-87f7-4205ba6dd1bb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-970-304335309703030 TABLET in 1 BOTTLE (43353-970-30) 30 tablet2014-10-090000-00-00NoNoCurrent