FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
50436-0611
11-digit product format
504360611
Labeler code
50436
Product ID
50436-0611_7a3642fc-7a63-46a6-831a-eaddf99ca591
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA077206
Marketing category
ANDA
Marketing start
2007-02-06
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 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
50436-0611-12021-01-29C16284748780-1ba0f9c33-1ac3-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
50436-0611-32021-01-29C16284748780-1ba0f9c33-1ac3-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0611-1Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
50436-0611-3Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0611SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 2 package rows20190222_a68c33e7-1276-4923-8211-2668e7ffe742.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312940sertraline HCl 25 MG Oral TabletPSNa68c33e7-1276-4923-8211-2668e7ffe7422
312940sertraline 25 MG Oral TabletSCDa68c33e7-1276-4923-8211-2668e7ffe7422
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYa68c33e7-1276-4923-8211-2668e7ffe7422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0611-15043606110130 in 1 BOTTLEHistorical
50436-0611-35043606110390 in 1 BOTTLEHistorical