FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
71335-3110
11-digit product format
713353110
Labeler code
71335
Product ID
71335-3110_30da61b0-fbef-47eb-9c70-3aa739c4c4a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077670
Marketing category
ANDA
Marketing start
2025-08-06
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 Hydrochloride
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
71335-3110-1Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
71335-3110-2Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
71335-3110-3Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901
71335-3110-4Sertraline Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1801
71335-3110-5Sertraline Hydrochloride28 in 1 BOTTLETABLET, FILM COATED281
71335-3110-6Sertraline Hydrochloride15 in 1 BOTTLETABLET, FILM COATED151
71335-3110-7Sertraline Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1201
71335-3110-8Sertraline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
71335-3110-9Sertraline Hydrochloride45 in 1 BOTTLETABLET, FILM COATED451

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNddbf623f-8b6f-4e8d-87d3-dc890c0ab8751
312938sertraline 100 MG Oral TabletSCDddbf623f-8b6f-4e8d-87d3-dc890c0ab8751
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYddbf623f-8b6f-4e8d-87d3-dc890c0ab8751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3110-17133531100130 TABLET, FILM COATED in 1 BOTTLE (71335-3110-1) 2026-03-30NoNoHistorical
71335-3110-27133531100260 TABLET, FILM COATED in 1 BOTTLE (71335-3110-2) 2026-03-30NoNoHistorical
71335-3110-37133531100390 TABLET, FILM COATED in 1 BOTTLE (71335-3110-3) 2026-03-30NoNoHistorical
71335-3110-471335311004180 TABLET, FILM COATED in 1 BOTTLE (71335-3110-4) 2026-03-30NoNoHistorical
71335-3110-57133531100528 TABLET, FILM COATED in 1 BOTTLE (71335-3110-5) 2026-03-30NoNoHistorical
71335-3110-67133531100615 TABLET, FILM COATED in 1 BOTTLE (71335-3110-6) 2026-03-30NoNoHistorical
71335-3110-771335311007120 TABLET, FILM COATED in 1 BOTTLE (71335-3110-7) 2026-03-30NoNoHistorical
71335-3110-871335311008100 TABLET, FILM COATED in 1 BOTTLE (71335-3110-8) 2026-03-30NoNoHistorical
71335-3110-97133531100945 TABLET, FILM COATED in 1 BOTTLE (71335-3110-9) 2026-03-30NoNoHistorical