FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
53002-1192
11-digit product format
530021192
Labeler code
53002
Product ID
53002-1192_124292ac-23fa-494e-b414-e3983f6d7a56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA077397
Marketing category
ANDA
Marketing start
2016-07-21
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
2021-12-31
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
53002-1192-02025-01-30C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-12025-01-30C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-32025-01-30C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-62025-01-30C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-02023-06-07C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-12023-06-07C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-32023-06-07C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-62023-06-07C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-02023-01-30C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-12023-01-30C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-32023-01-30C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-62023-01-30C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-02020-12-15C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-12020-12-15C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-32020-12-15C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-62020-12-15C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-02020-01-31C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-12020-01-31C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-32020-01-31C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-62020-01-31C16284748780-19d75b9d1-1e3f-f424-e053-dadaa90a57ceThese 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
53002-1192-0Sertraline Hydrochloride100 in 1 BOTTLETABLET10010
53002-1192-1Sertraline Hydrochloride10 in 1 BOTTLETABLET1010
53002-1192-3Sertraline Hydrochloride30 in 1 BOTTLETABLET3010
53002-1192-6Sertraline Hydrochloride60 in 1 BOTTLETABLET6010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1192SERTRALINE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]10Legacy NDC, 4 package rows20230609_d8102ff3-2b91-461d-9b99-f73443d8578d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNd8102ff3-2b91-461d-9b99-f73443d8578d10
312940sertraline HCl 25 MG Oral TabletPSNd8102ff3-2b91-461d-9b99-f73443d8578d10
312941sertraline HCl 50 MG Oral TabletPSNd8102ff3-2b91-461d-9b99-f73443d8578d10
312938sertraline 100 MG Oral TabletSCDd8102ff3-2b91-461d-9b99-f73443d8578d10
312940sertraline 25 MG Oral TabletSCDd8102ff3-2b91-461d-9b99-f73443d8578d10
312941sertraline 50 MG Oral TabletSCDd8102ff3-2b91-461d-9b99-f73443d8578d10
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYd8102ff3-2b91-461d-9b99-f73443d8578d10
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYd8102ff3-2b91-461d-9b99-f73443d8578d10
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYd8102ff3-2b91-461d-9b99-f73443d8578d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1192-053002119200100 TABLET in 1 BOTTLE (53002-1192-0) 100 tablet2017-09-010000-00-00NoNoCurrent
53002-1192-15300211920110 TABLET in 1 BOTTLE (53002-1192-1) 10 tablet2017-09-010000-00-00NoNoCurrent
53002-1192-35300211920330 TABLET in 1 BOTTLE (53002-1192-3) 30 tablet2017-09-010000-00-00NoNoCurrent
53002-1192-65300211920660 TABLET in 1 BOTTLE (53002-1192-6) 60 tablet2017-09-010000-00-00NoNoCurrent