FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
71335-0328
11-digit product format
713350328
Labeler code
71335
Product ID
71335-0328_0b420eee-e7ab-473f-82ee-254286e4a8aa
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
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312940

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
71335-0328-12024-05-17C16284748780-11030e365-6928-111a-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
71335-0328-22024-05-17C16284748780-11030e365-6928-111a-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
71335-0328-32024-05-17C16284748780-11030e365-6928-111a-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
71335-0328-42024-05-17C16284748780-11030e365-6928-111a-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
71335-0328-52024-05-17C16284748780-11030e365-6928-111a-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
71335-0328-62024-05-17C16284748780-11030e365-6928-111a-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
71335-0328-12024-01-30C16284748780-11030e365-6928-111a-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
71335-0328-22024-01-30C16284748780-11030e365-6928-111a-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
71335-0328-32024-01-30C16284748780-11030e365-6928-111a-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
71335-0328-42024-01-30C16284748780-11030e365-6928-111a-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
71335-0328-52024-01-30C16284748780-11030e365-6928-111a-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
71335-0328-62024-01-30C16284748780-11030e365-6928-111a-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
71335-0328-1Sertraline Hydrochloride30 in 1 BOTTLETABLET308
71335-0328-2Sertraline Hydrochloride60 in 1 BOTTLETABLET608
71335-0328-3Sertraline Hydrochloride90 in 1 BOTTLETABLET908
71335-0328-4Sertraline Hydrochloride180 in 1 BOTTLETABLET1808
71335-0328-5Sertraline Hydrochloride28 in 1 BOTTLETABLET288
71335-0328-6Sertraline Hydrochloride120 in 1 BOTTLETABLET1208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0328-1EA - Each71335-0328d3a965aa-f9b0-411c-be9e-398a1ab06d7712022-11-07
71335-0328-2EA - Each71335-0328a2874e00-da22-44bf-a01a-33fb1493deab12022-11-07
71335-0328-3EA - Each71335-03282dae5b02-eba4-4cb7-a03c-25928f86103212022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0328SERTRALINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 6 package rows20240518_22c4b114-5f70-4c64-aa7f-b4169729b847.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312940sertraline HCl 25 MG Oral TabletPSN22c4b114-5f70-4c64-aa7f-b4169729b8478
312940sertraline 25 MG Oral TabletSCD22c4b114-5f70-4c64-aa7f-b4169729b8478
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY22c4b114-5f70-4c64-aa7f-b4169729b8478

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0328-17133503280130 TABLET in 1 BOTTLE (71335-0328-1) 30 tablet2018-02-130000-00-00NoNoCurrent
71335-0328-27133503280260 TABLET in 1 BOTTLE (71335-0328-2) 60 tablet2018-02-200000-00-00NoNoCurrent
71335-0328-37133503280390 TABLET in 1 BOTTLE (71335-0328-3) 90 tablet2018-02-260000-00-00NoNoCurrent
71335-0328-471335032804180 TABLET in 1 BOTTLE (71335-0328-4) 180 tablet2021-12-270000-00-00NoNoCurrent
71335-0328-57133503280528 TABLET in 1 BOTTLE (71335-0328-5) 28 tablet2021-12-270000-00-00NoNoCurrent
71335-0328-671335032806120 TABLET in 1 BOTTLE (71335-0328-6) 120 tablet2021-12-270000-00-00NoNoCurrent