FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
53002-3192
11-digit product format
530023192
Labeler code
53002
Product ID
53002-3192_847c7b3d-3633-4927-8e13-fec383d44591
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA077206
Marketing category
ANDA
Marketing start
2007-02-06
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
50 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
53002-3192-02025-01-30C16284748780-1f386c64a-2b88-0266-e053-dadaa90a7c1aThese 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
53002-3192-12025-01-30C16284748780-1f386c64a-2b88-0266-e053-dadaa90a7c1aThese 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
53002-3192-32025-01-30C16284748780-1f386c64a-2b88-0266-e053-dadaa90a7c1aThese 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
53002-3192-62025-01-30C16284748780-1f386c64a-2b88-0266-e053-dadaa90a7c1aThese 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
53002-3192-02023-06-07C16284748780-1f386c64a-2b88-0266-e053-dadaa90a7c1aThese 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
53002-3192-12023-06-07C16284748780-1f386c64a-2b88-0266-e053-dadaa90a7c1aThese 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
53002-3192-32023-06-07C16284748780-1f386c64a-2b88-0266-e053-dadaa90a7c1aThese 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
53002-3192-62023-06-07C16284748780-1f386c64a-2b88-0266-e053-dadaa90a7c1aThese 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
53002-3192-02023-01-30C16284748780-1f386c64a-2b88-0266-e053-dadaa90a7c1aThese 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
53002-3192-12023-01-30C16284748780-1f386c64a-2b88-0266-e053-dadaa90a7c1aThese 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
53002-3192-32023-01-30C16284748780-1f386c64a-2b88-0266-e053-dadaa90a7c1aThese 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
53002-3192-62023-01-30C16284748780-1f386c64a-2b88-0266-e053-dadaa90a7c1aThese 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
53002-3192-0Sertraline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005
53002-3192-1Sertraline Hydrochloride10 in 1 BOTTLETABLET, FILM COATED105
53002-3192-3Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
53002-3192-6Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3192SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 4 package rows20230609_6c90d88f-3e9c-4306-9e82-6dbc831787a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN6c90d88f-3e9c-4306-9e82-6dbc831787a15
312941sertraline 50 MG Oral TabletSCD6c90d88f-3e9c-4306-9e82-6dbc831787a15
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY6c90d88f-3e9c-4306-9e82-6dbc831787a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-3192-053002319200100 TABLET, FILM COATED in 1 BOTTLE (53002-3192-0) 2019-01-010000-00-00NoNoCurrent
53002-3192-15300231920110 TABLET, FILM COATED in 1 BOTTLE (53002-3192-1) 2019-01-010000-00-00NoNoCurrent
53002-3192-35300231920330 TABLET, FILM COATED in 1 BOTTLE (53002-3192-3) 2019-01-010000-00-00NoNoCurrent
53002-3192-65300231920660 TABLET, FILM COATED in 1 BOTTLE (53002-3192-6) 2019-01-010000-00-00NoNoCurrent