FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
53808-1127
11-digit product format
538081127
Labeler code
53808
Product ID
53808-1127_8a1e2384-3655-4c66-b1c1-0e4741f5a2d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DOH CENTRAL PHARMACY
Application
ANDA077206
Marketing category
ANDA
Marketing start
2018-09-04
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
53808-1127-12024-01-30C16284748780-11030e365-1f42-111a-e063-dadaa90a10e2These 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
53808-1127-1Sertraline Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1127SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20190125_5be1d245-ccd6-4782-a1d6-dde9b963f5ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN5be1d245-ccd6-4782-a1d6-dde9b963f5ab1
312938sertraline 100 MG Oral TabletSCD5be1d245-ccd6-4782-a1d6-dde9b963f5ab1
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY5be1d245-ccd6-4782-a1d6-dde9b963f5ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53808-1127-15380811270130 TABLET, FILM COATED in 1 BLISTER PACK (53808-1127-1) 2018-09-040000-00-00NoNoCurrent