FDA.reportPublic FDA data

Sertraline

Product NDC
71335-3115
11-digit product format
713353115
Labeler code
71335
Product ID
71335-3115_d5a00c50-f44a-4234-a60d-35178ee025dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076465
Marketing category
ANDA
Marketing start
2023-02-23
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sertraline
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3115-1Sertraline30 in 1 BOTTLETABLET, FILM COATED301
71335-3115-2Sertraline60 in 1 BOTTLETABLET, FILM COATED601
71335-3115-3Sertraline90 in 1 BOTTLETABLET, FILM COATED901
71335-3115-4Sertraline180 in 1 BOTTLETABLET, FILM COATED1801
71335-3115-5Sertraline28 in 1 BOTTLETABLET, FILM COATED281
71335-3115-6Sertraline15 in 1 BOTTLETABLET, FILM COATED151
71335-3115-7Sertraline120 in 1 BOTTLETABLET, FILM COATED1201
71335-3115-8Sertraline100 in 1 BOTTLETABLET, FILM COATED1001
71335-3115-9Sertraline45 in 1 BOTTLETABLET, FILM COATED451

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN03e1f274-fa9a-4461-b7c9-31ba6428c1071
312938sertraline 100 MG Oral TabletSCD03e1f274-fa9a-4461-b7c9-31ba6428c1071
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY03e1f274-fa9a-4461-b7c9-31ba6428c1071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3115-17133531150130 TABLET, FILM COATED in 1 BOTTLE (71335-3115-1) 2026-03-30NoNoHistorical
71335-3115-27133531150260 TABLET, FILM COATED in 1 BOTTLE (71335-3115-2) 2026-03-30NoNoHistorical
71335-3115-37133531150390 TABLET, FILM COATED in 1 BOTTLE (71335-3115-3) 2026-03-30NoNoHistorical
71335-3115-471335311504180 TABLET, FILM COATED in 1 BOTTLE (71335-3115-4) 2026-03-30NoNoHistorical
71335-3115-57133531150528 TABLET, FILM COATED in 1 BOTTLE (71335-3115-5) 2026-03-30NoNoHistorical
71335-3115-67133531150615 TABLET, FILM COATED in 1 BOTTLE (71335-3115-6) 2026-03-30NoNoHistorical
71335-3115-771335311507120 TABLET, FILM COATED in 1 BOTTLE (71335-3115-7) 2026-03-30NoNoHistorical
71335-3115-871335311508100 TABLET, FILM COATED in 1 BOTTLE (71335-3115-8) 2026-03-30NoNoHistorical
71335-3115-97133531150945 TABLET, FILM COATED in 1 BOTTLE (71335-3115-9) 2026-03-30NoNoHistorical