FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
70518-4518
11-digit product format
705184518
Labeler code
70518
Product ID
70518-4518_50ac571a-82ed-b876-e063-6294a90ae333
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077670
Marketing category
ANDA
Marketing start
2025-11-10
Substance
SERTRALINE HYDROCHLORIDE
Active strength
50 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 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
70518-4518-0Sertraline Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED305
70518-4518-1Sertraline Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED305
70518-4518-2Sertraline Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED305
70518-4518-3Sertraline Hydrochloride50 in 1 BOXTABLET, FILM COATED505
70518-4518-4Sertraline Hydrochloride1 in 1 POUCHTABLET, FILM COATED15
70518-4518-5Sertraline Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED305

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSNcac718b8-64bc-4aca-9b22-f2b00077bd415
312941sertraline 50 MG Oral TabletSCDcac718b8-64bc-4aca-9b22-f2b00077bd415
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYcac718b8-64bc-4aca-9b22-f2b00077bd415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4518-07051845180030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4518-0) 2025-11-10NoNoHistorical
70518-4518-17051845180130 TABLET, FILM COATED in 1 BLISTER PACK (70518-4518-1) 2026-02-04NoNoHistorical
70518-4518-27051845180230 TABLET, FILM COATED in 1 BLISTER PACK (70518-4518-2) 2026-03-20NoNoHistorical
70518-4518-37051845180350 POUCH in 1 BOX (70518-4518-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-4518-4) 50 pouch2026-04-22NoNoHistorical
70518-4518-4705184518041 in 1 POUCHHistorical
70518-4518-57051845180530 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4518-5) 2026-04-29NoNoHistorical