FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
68788-8210
11-digit product format
687888210
Labeler code
68788
Product ID
68788-8210_196dbe6f-50a6-4adc-9fc2-901e1a658ac9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SERTRALINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202825
Marketing category
ANDA
Marketing start
2022-06-06
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
68788-8210-3SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED304
68788-8210-6SERTRALINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED604
68788-8210-9SERTRALINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8210-3EA - Each68788-821090d7af72-c813-4da0-bb5b-c3cd8754e95212022-07-06
68788-8210-6EA - Each68788-821038999d27-6ae2-425d-bf03-80122665842612022-07-06
68788-8210-9EA - Each68788-82103708c2d3-2132-490d-bade-04d65b0e7b8812022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8210SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 3 package rows20240810_2beb45ca-0ebb-4908-807a-7413250693e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN2beb45ca-0ebb-4908-807a-7413250693e34
312938sertraline 100 MG Oral TabletSCD2beb45ca-0ebb-4908-807a-7413250693e34
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY2beb45ca-0ebb-4908-807a-7413250693e34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8210-36878882100330 TABLET, FILM COATED in 1 BOTTLE (68788-8210-3) 2022-06-060000-00-00NoNoCurrent
68788-8210-66878882100660 TABLET, FILM COATED in 1 BOTTLE (68788-8210-6) 2022-06-060000-00-00NoNoCurrent
68788-8210-96878882100990 TABLET, FILM COATED in 1 BOTTLE (68788-8210-9) 2022-06-060000-00-00NoNoCurrent