FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
50436-0013
11-digit product format
504360013
Labeler code
50436
Product ID
50436-0013_bc5ae863-68ae-43e8-8d61-515d3f873311
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
100 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
50436-0013-12021-01-29C16284748780-1ba0f9c33-4dc9-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
50436-0013-32021-01-29C16284748780-1ba0f9c33-4dc9-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
50436-0013-1Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
50436-0013-3Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0013SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES]4Legacy NDC, 2 package rows20190222_06c47a1b-e41a-457d-8a4f-863cece11d1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN06c47a1b-e41a-457d-8a4f-863cece11d1c4
312940sertraline HCl 25 MG Oral TabletPSN06c47a1b-e41a-457d-8a4f-863cece11d1c4
312941sertraline HCl 50 MG Oral TabletPSN06c47a1b-e41a-457d-8a4f-863cece11d1c4
312938sertraline 100 MG Oral TabletSCD06c47a1b-e41a-457d-8a4f-863cece11d1c4
312940sertraline 25 MG Oral TabletSCD06c47a1b-e41a-457d-8a4f-863cece11d1c4
312941sertraline 50 MG Oral TabletSCD06c47a1b-e41a-457d-8a4f-863cece11d1c4
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY06c47a1b-e41a-457d-8a4f-863cece11d1c4
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY06c47a1b-e41a-457d-8a4f-863cece11d1c4
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY06c47a1b-e41a-457d-8a4f-863cece11d1c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0013-15043600130130 in 1 BOTTLEHistorical
50436-0013-35043600130390 in 1 BOTTLEHistorical