FDA.reportPublic FDA data

SERTRALINE

Product NDC
50090-3562
11-digit product format
500903562
Labeler code
50090
Product ID
50090-3562_397286b7-fad7-48da-96e9-09f00473cd3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077397
Marketing category
ANDA
Marketing start
2012-08-20
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
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
50090-3562-02023-01-30C16284748780-1f386c649-ed09-0266-e053-dadaa90a7c1aThese 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
50090-3562-12023-01-30C16284748780-1f386c649-ed09-0266-e053-dadaa90a7c1aThese 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
50090-3562-0SERTRALINE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED305
50090-3562-1SERTRALINE90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3562SERTRALINE (SERTRALINE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20210417_b25caa0a-a438-43de-b280-5c81d162e993.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312940sertraline HCl 25 MG Oral TabletPSNb25caa0a-a438-43de-b280-5c81d162e9935
312940sertraline 25 MG Oral TabletSCDb25caa0a-a438-43de-b280-5c81d162e9935
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYb25caa0a-a438-43de-b280-5c81d162e9935

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3562-05009035620030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3562-0) 2014-11-280000-00-00NoNoCurrent
50090-3562-15009035620190 TABLET, FILM COATED in 1 BOTTLE (50090-3562-1) 2018-08-300000-00-00NoNoCurrent