FDA.reportPublic FDA data

Sertraline

Product NDC
71335-9714
11-digit product format
713359714
Labeler code
71335
Product ID
71335-9714_3101cb97-1e74-4088-8d1c-7f6870c0f145
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077670
Marketing category
ANDA
Marketing start
2007-02-06
Substance
SERTRALINE HYDROCHLORIDE
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312941

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ac594ea-ad8b-47fd-9b52-bbd98301675eProduct name120220317
255fa467-900b-5557-4215-6823352d1150Product name220211028

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9714-1Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30103
71335-9714-2Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60103
71335-9714-3Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90103
71335-9714-4Sertraline Hydrochloride180 in 1 BOTTLETABLET, FILM COATED180103
71335-9714-5Sertraline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100103
71335-9714-6Sertraline Hydrochloride56 in 1 BOTTLETABLET, FILM COATED56103
71335-9714-7Sertraline Hydrochloride28 in 1 BOTTLETABLET, FILM COATED28103
71335-9714-8Sertraline Hydrochloride120 in 1 BOTTLETABLET, FILM COATED120103
71335-9714-9Sertraline Hydrochloride15 in 1 BOTTLETABLET, FILM COATED15103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9714-1EA - Each71335-9714224b75c7-acc5-465a-af2f-812a06ab927312024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9714SERTRALINE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, 9 package rows20240830_6c26a87a-b2b6-4302-bb8d-2031461f28ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN6c26a87a-b2b6-4302-bb8d-2031461f28ce103
312941sertraline 50 MG Oral TabletSCD6c26a87a-b2b6-4302-bb8d-2031461f28ce103
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY6c26a87a-b2b6-4302-bb8d-2031461f28ce103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9714-17133597140130 TABLET, FILM COATED in 1 BOTTLE (71335-9714-1) 2023-05-12NoNoCurrent
71335-9714-27133597140260 TABLET, FILM COATED in 1 BOTTLE (71335-9714-2) 2023-07-17NoNoCurrent
71335-9714-37133597140390 TABLET, FILM COATED in 1 BOTTLE (71335-9714-3) 2023-05-11NoNoCurrent
71335-9714-471335971404180 TABLET, FILM COATED in 1 BOTTLE (71335-9714-4) 2026-04-10NoNoCurrent
71335-9714-571335971405100 TABLET, FILM COATED in 1 BOTTLE (71335-9714-5) 2026-04-10NoNoCurrent
71335-9714-67133597140656 TABLET, FILM COATED in 1 BOTTLE (71335-9714-6) 2026-04-10NoNoCurrent
71335-9714-77133597140728 TABLET, FILM COATED in 1 BOTTLE (71335-9714-7) 2026-04-10NoNoCurrent
71335-9714-871335971408120 TABLET, FILM COATED in 1 BOTTLE (71335-9714-8) 2026-04-10NoNoCurrent
71335-9714-97133597140915 TABLET, FILM COATED in 1 BOTTLE (71335-9714-9) 2026-04-10NoNoCurrent