FDA.reportPublic FDA data

Sertraline

Product NDC
50268-768
11-digit product format
502680768
Labeler code
50268
Product ID
50268-768_48364c4d-880c-1d77-e063-6294a90a9011
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA077670
Marketing category
ANDA
Marketing start
2024-02-06
Substance
SERTRALINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312938, 312940, 312941

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
50268-768-11Sertraline1 in 1 BLISTER PACKTABLET, FILM COATED12
50268-768-15Sertraline50 in 1 BOXTABLET, FILM COATED502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-768-11EA - Each50268-768e7f35c3d-eea8-4d44-89f1-3192f28e596112024-03-12
50268-768-15EA - Each50268-768a75cb5d6-4b0a-4f04-9c78-9759f5520ffa12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-768SERTRALINE TABLET, FILM COATED [AVPAK]1Current NDC, 2 package rows20240207_10baaffd-061e-d665-e063-6294a90a1594.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN10baaffd-061e-d665-e063-6294a90a15942
312940sertraline HCl 25 MG Oral TabletPSN10baaffd-061e-d665-e063-6294a90a15942
312941sertraline HCl 50 MG Oral TabletPSN10baaffd-061e-d665-e063-6294a90a15942
312938sertraline 100 MG Oral TabletSCD10baaffd-061e-d665-e063-6294a90a15942
312940sertraline 25 MG Oral TabletSCD10baaffd-061e-d665-e063-6294a90a15942
312941sertraline 50 MG Oral TabletSCD10baaffd-061e-d665-e063-6294a90a15942
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY10baaffd-061e-d665-e063-6294a90a15942
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY10baaffd-061e-d665-e063-6294a90a15942
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY10baaffd-061e-d665-e063-6294a90a15942

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-768-11502680768111 in 1 BLISTER PACKHistorical
50268-768-155026807681550 BLISTER PACK in 1 BOX (50268-768-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-768-11) 50 blister pack2024-02-06NoNoHistorical