FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
53002-4215
11-digit product format
530024215
Labeler code
53002
Product ID
53002-4215_dfc0f5e1-2242-41bc-ad38-a36c424b4043
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SERTRALINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA202825
Marketing category
ANDA
Marketing start
2017-02-09
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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
53002-4215-02025-01-30C16284748780-12cef2736-a499-d83d-e063-dadaa90ab31fThese 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
53002-4215-32025-01-30C16284748780-12cef2736-a499-d83d-e063-dadaa90ab31fThese 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
53002-4215-62025-01-30C16284748780-12cef2736-a499-d83d-e063-dadaa90ab31fThese 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
53002-4215-0SERTRALINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1001
53002-4215-3SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED301
53002-4215-6SERTRALINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4215SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 3 package rows20220331_5c5b5d44-1efd-4853-80a6-3dcb21d5010f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN5c5b5d44-1efd-4853-80a6-3dcb21d5010f1
312938sertraline 100 MG Oral TabletSCD5c5b5d44-1efd-4853-80a6-3dcb21d5010f1
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY5c5b5d44-1efd-4853-80a6-3dcb21d5010f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-4215-053002421500100 TABLET, FILM COATED in 1 BOTTLE (53002-4215-0) 2021-01-010000-00-00NoNoCurrent
53002-4215-35300242150330 TABLET, FILM COATED in 1 BOTTLE (53002-4215-3) 2021-01-010000-00-00NoNoCurrent
53002-4215-65300242150660 TABLET, FILM COATED in 1 BOTTLE (53002-4215-6) 2021-01-010000-00-00NoNoCurrent