FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
68788-6835
11-digit product format
687886835
Labeler code
68788
Product ID
68788-6835_1a6f3793-c507-4d36-85da-0c482e695c6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077206
Marketing category
ANDA
Marketing start
2016-11-21
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sertraline Hydrochloride
Listing expiration
2026-12-31

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
68788-6835-1Sertraline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10010
68788-6835-2Sertraline Hydrochloride28 in 1 BOTTLETABLET, FILM COATED2810
68788-6835-3Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3010
68788-6835-6Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6010
68788-6835-8Sertraline Hydrochloride120 in 1 BOTTLETABLET, FILM COATED12010
68788-6835-9Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-6835-1EA - Each68788-683526878578-e934-41fc-9119-2fecd42f54c612021-04-08
68788-6835-3EA - Each68788-6835d8535809-296b-4202-b3be-123598f8606812021-04-08
68788-6835-6EA - Each68788-6835c68058f4-a58b-4c21-b941-15535ef7cc8d12021-04-08
68788-6835-8EA - Each68788-683589b71cb0-ecbd-42c7-a8a3-4d2bda33873f12021-04-08
68788-6835-9EA - Each68788-68358ec0ee98-be22-46e0-8a7a-27352ae3151712021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-6835SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 6 package rows20240810_677c90cd-6527-40cb-a564-571796513fcb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN677c90cd-6527-40cb-a564-571796513fcb10
312938sertraline 100 MG Oral TabletSCD677c90cd-6527-40cb-a564-571796513fcb10
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY677c90cd-6527-40cb-a564-571796513fcb10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-6835-168788683501100 TABLET, FILM COATED in 1 BOTTLE (68788-6835-1) 2016-11-210000-00-00NoNoCurrent
68788-6835-26878868350228 TABLET, FILM COATED in 1 BOTTLE (68788-6835-2) 2016-11-210000-00-00NoNoCurrent
68788-6835-36878868350330 TABLET, FILM COATED in 1 BOTTLE (68788-6835-3) 2016-11-210000-00-00NoNoCurrent
68788-6835-66878868350660 TABLET, FILM COATED in 1 BOTTLE (68788-6835-6) 2016-11-210000-00-00NoNoCurrent
68788-6835-868788683508120 TABLET, FILM COATED in 1 BOTTLE (68788-6835-8) 2016-11-210000-00-00NoNoCurrent
68788-6835-96878868350990 TABLET, FILM COATED in 1 BOTTLE (68788-6835-9) 2016-11-210000-00-00NoNoCurrent