Sertraline Hydrochloride

Product NDC
50090-2976
11-digit product format
500902976
Labeler code
50090
Product ID
50090-2976_5b4d8203-6b8b-4f3b-9baa-260b0b838092
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
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
25 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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
50090-2976-0Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3022
50090-2976-1Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2976SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]22Legacy NDC, 2 package rows20210911_44d9d754-f4da-4792-9e23-93faad0bffd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN44d9d754-f4da-4792-9e23-93faad0bffd122
312940sertraline HCl 25 MG Oral TabletPSN44d9d754-f4da-4792-9e23-93faad0bffd122
312941sertraline HCl 50 MG Oral TabletPSN44d9d754-f4da-4792-9e23-93faad0bffd122
312938sertraline 100 MG Oral TabletSCD44d9d754-f4da-4792-9e23-93faad0bffd122
312940sertraline 25 MG Oral TabletSCD44d9d754-f4da-4792-9e23-93faad0bffd122
312941sertraline 50 MG Oral TabletSCD44d9d754-f4da-4792-9e23-93faad0bffd122
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY44d9d754-f4da-4792-9e23-93faad0bffd122
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY44d9d754-f4da-4792-9e23-93faad0bffd122
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY44d9d754-f4da-4792-9e23-93faad0bffd122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2976-05009029760030 TABLET, FILM COATED in 1 BOTTLE (50090-2976-0) 2017-04-180000-00-00NoNoCurrent
50090-2976-15009029760190 TABLET, FILM COATED in 1 BOTTLE (50090-2976-1) 2018-06-120000-00-00NoNoCurrent