FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
70518-2448
11-digit product format
705182448
Labeler code
70518
Product ID
70518-2448_4caf596e-80d6-8546-e063-6294a90ac27c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077206
Marketing category
ANDA
Marketing start
2019-11-23
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 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
70518-2448-0Sertraline Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED3014
70518-2448-1Sertraline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9014
70518-2448-2Sertraline Hydrochloride28 in 1 BLISTER PACKTABLET, FILM COATED2814
70518-2448-3Sertraline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9014
70518-2448-4Sertraline Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6014
70518-2448-5Sertraline Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED3014
70518-2448-6Sertraline Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED3014
70518-2448-7Sertraline Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3014
70518-2448-8Sertraline Hydrochloride45 in 1 BOTTLE, PLASTICTABLET, FILM COATED4514

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2448SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 9 package rows20250210_a2f333af-d37b-4705-ab7a-d363e3186e6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNa2f333af-d37b-4705-ab7a-d363e3186e6e14
312938sertraline 100 MG Oral TabletSCDa2f333af-d37b-4705-ab7a-d363e3186e6e14
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYa2f333af-d37b-4705-ab7a-d363e3186e6e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2448-07051824480030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2448-0) 2019-11-230000-00-00NoNoCurrent
70518-2448-17051824480190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2448-1) 2020-06-040000-00-00NoNoCurrent
70518-2448-27051824480228 TABLET, FILM COATED in 1 BLISTER PACK (70518-2448-2) 2020-07-220000-00-00NoNoCurrent
70518-2448-37051824480390 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2448-3) 2020-07-220000-00-00NoNoCurrent
70518-2448-47051824480460 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2448-4) 2020-12-220000-00-00NoNoCurrent
70518-2448-57051824480530 TABLET, FILM COATED in 1 BLISTER PACK (70518-2448-5) 2021-10-130000-00-00NoNoCurrent
70518-2448-67051824480630 in 1 BLISTER PACKHistorical
70518-2448-77051824480730 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2448-7) 2025-06-18NoNoHistorical
70518-2448-87051824480845 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2448-8) 2026-03-10NoNoHistorical