Sertraline Hydrochloride

Product NDC
50090-3153
11-digit product format
500903153
Labeler code
50090
Product ID
50090-3153_00505861-5878-4443-ad46-af75309d425b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077397
Marketing category
ANDA
Marketing start
2016-07-21
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
50 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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ac594ea-ad8b-47fd-9b52-bbd98301675eProduct name120220317
255fa467-900b-5557-4215-6823352d1150Product name220211028

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3153-0Sertraline Hydrochloride1 in 1 BLISTER PACKTABLET13
50090-3153-0Sertraline Hydrochloride33 in 1 BOX, UNIT-DOSETABLET333

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3153SERTRALINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20190627_2f7dea8d-9af7-4e56-a57a-8b6f81206219.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN2f7dea8d-9af7-4e56-a57a-8b6f812062193
312941sertraline 50 MG Oral TabletSCD2f7dea8d-9af7-4e56-a57a-8b6f812062193
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY2f7dea8d-9af7-4e56-a57a-8b6f812062193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3153-05009031530033 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-3153-0) > 1 TABLET in 1 BLISTER PACK33 blister pack2017-10-040000-00-00NoNoCurrent