Sertraline Hydrochloride

Product NDC
50090-2609
11-digit product format
500902609
Labeler code
50090
Product ID
50090-2609_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
100 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2609-02023-01-30C16284748780-19d75b9d0-635b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SERTRALINE TABLETS safely and effectively. See full prescribing information for SERTRALINE TABLETS. SERTRALINE tablets, for oral use Initial U.S. Approval: 1991
50090-2609-22023-01-30C16284748780-19d75b9d0-635b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SERTRALINE TABLETS safely and effectively. See full prescribing information for SERTRALINE TABLETS. SERTRALINE tablets, for oral use Initial U.S. Approval: 1991
50090-2609-02021-09-10C16284748780-19d75b9d0-635b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SERTRALINE TABLETS safely and effectively. See full prescribing information for SERTRALINE TABLETS. SERTRALINE tablets, for oral use Initial U.S. Approval: 1991
50090-2609-22021-09-10C16284748780-19d75b9d0-635b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SERTRALINE TABLETS safely and effectively. See full prescribing information for SERTRALINE TABLETS. SERTRALINE tablets, for oral use Initial U.S. Approval: 1991
50090-2609-02020-01-31C16284748780-19d75b9d0-635b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SERTRALINE TABLETS safely and effectively. See full prescribing information for SERTRALINE TABLETS. SERTRALINE tablets, for oral use Initial U.S. Approval: 1991
50090-2609-22020-01-31C16284748780-19d75b9d0-635b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SERTRALINE TABLETS safely and effectively. See full prescribing information for SERTRALINE TABLETS. SERTRALINE tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2609-0Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3022
50090-2609-2Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2609SERTRALINE 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
50090-2609-05009026090030 TABLET, FILM COATED in 1 BOTTLE (50090-2609-0) 2016-11-160000-00-00NoNoCurrent
50090-2609-25009026090290 TABLET, FILM COATED in 1 BOTTLE (50090-2609-2) 2016-11-100000-00-00NoNoCurrent