FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
71335-0896
11-digit product format
713350896
Labeler code
71335
Product ID
71335-0896_61f43983-c03a-4c7e-b6c4-e66aaa621ff7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077397
Marketing category
ANDA
Marketing start
2016-07-21
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sertraline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312938

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
71335-0896-12024-05-16C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-22024-05-16C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-32024-05-16C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-42024-05-16C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-52024-05-16C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-62024-05-16C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-72024-05-16C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-82024-05-16C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-92024-05-16C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-12024-01-30C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-22024-01-30C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-32024-01-30C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-42024-01-30C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-52024-01-30C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-62024-01-30C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-72024-01-30C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-82024-01-30C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-92024-01-30C16284748780-11030e365-6bc3-111a-e063-dadaa90a10e2These 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
71335-0896-1Sertraline Hydrochloride30 in 1 BOTTLETABLET30101
71335-0896-2Sertraline Hydrochloride60 in 1 BOTTLETABLET60101
71335-0896-3Sertraline Hydrochloride90 in 1 BOTTLETABLET90101
71335-0896-4Sertraline Hydrochloride180 in 1 BOTTLETABLET180101
71335-0896-5Sertraline Hydrochloride28 in 1 BOTTLETABLET28101
71335-0896-6Sertraline Hydrochloride15 in 1 BOTTLETABLET15101
71335-0896-7Sertraline Hydrochloride120 in 1 BOTTLETABLET120101
71335-0896-8Sertraline Hydrochloride100 in 1 BOTTLETABLET100101
71335-0896-9Sertraline Hydrochloride45 in 1 BOTTLETABLET45101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0896-1EA - Each71335-08968918272d-e172-47e7-899e-cb7a16e7d97712019-09-05
71335-0896-2EA - Each71335-0896967410c0-eae0-47bc-8aa5-395e4cb237ee12019-09-05
71335-0896-3EA - Each71335-0896584c3ad9-5c47-4672-8a04-48c2108188ec12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0896SERTRALINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 9 package rows20240517_9bcef7ef-4e2f-4ab9-9c0f-f4956bfdd71b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN9bcef7ef-4e2f-4ab9-9c0f-f4956bfdd71b101
312938sertraline 100 MG Oral TabletSCD9bcef7ef-4e2f-4ab9-9c0f-f4956bfdd71b101
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY9bcef7ef-4e2f-4ab9-9c0f-f4956bfdd71b101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0896-17133508960130 TABLET in 1 BOTTLE (71335-0896-1) 30 tablet2022-02-090000-00-00NoNoCurrent
71335-0896-27133508960260 TABLET in 1 BOTTLE (71335-0896-2) 60 tablet2022-02-090000-00-00NoNoCurrent
71335-0896-37133508960390 TABLET in 1 BOTTLE (71335-0896-3) 90 tablet2022-02-090000-00-00NoNoCurrent
71335-0896-471335089604180 TABLET in 1 BOTTLE (71335-0896-4) 180 tablet2022-02-090000-00-00NoNoCurrent
71335-0896-57133508960528 TABLET in 1 BOTTLE (71335-0896-5) 28 tablet2022-02-090000-00-00NoNoCurrent
71335-0896-67133508960615 TABLET in 1 BOTTLE (71335-0896-6) 15 tablet2022-02-090000-00-00NoNoCurrent
71335-0896-771335089607120 TABLET in 1 BOTTLE (71335-0896-7) 120 tablet2022-02-090000-00-00NoNoCurrent
71335-0896-871335089608100 TABLET in 1 BOTTLE (71335-0896-8) 100 tablet2022-02-090000-00-00NoNoCurrent
71335-0896-97133508960945 TABLET in 1 BOTTLE (71335-0896-9) 45 tablet2022-02-090000-00-00NoNoCurrent