FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
70518-2812
11-digit product format
705182812
Labeler code
70518
Product ID
70518-2812_4e8db3cc-f092-5a4a-e063-6394a90a43b4
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
2020-07-10
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
70518-2812-0Sertraline Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED3013
70518-2812-1Sertraline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9013
70518-2812-2Sertraline Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3013
70518-2812-3Sertraline Hydrochloride28 in 1 BLISTER PACKTABLET, FILM COATED2813
70518-2812-4Sertraline Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED3013
70518-2812-5Sertraline Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2812SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 6 package rows20250221_91e24d17-ff0a-449c-9472-b9df74c98456.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN91e24d17-ff0a-449c-9472-b9df74c9845613
312941sertraline 50 MG Oral TabletSCD91e24d17-ff0a-449c-9472-b9df74c9845613
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY91e24d17-ff0a-449c-9472-b9df74c9845613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2812-07051828120030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2812-0) 2020-07-100000-00-00NoNoCurrent
70518-2812-17051828120190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2812-1) 2020-08-150000-00-00NoNoCurrent
70518-2812-27051828120230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2812-2) 2020-11-020000-00-00NoNoCurrent
70518-2812-37051828120328 TABLET, FILM COATED in 1 BLISTER PACK (70518-2812-3) 2021-01-040000-00-00NoNoCurrent
70518-2812-47051828120430 TABLET, FILM COATED in 1 BLISTER PACK (70518-2812-4) 2021-12-290000-00-00NoNoCurrent
70518-2812-57051828120530 in 1 BOTTLE, PLASTICHistorical