Sertraline Hydrochloride

Product NDC
50090-7830
11-digit product format
500907830
Labeler code
50090
Product ID
50090-7830_8a13e02d-bd0c-4e64-a7d8-f0ad0c775602
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077670
Marketing category
ANDA
Marketing start
2007-02-06
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
UTI8907Y6XSERTRALINE HYDROCHLORIDE79559-97-0SERTRALINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7830-05009078300090 TABLET, FILM COATED in 1 BOTTLE (50090-7830-0) 2025-12-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Sertraline HydrochlorideA-S Medication Solutions2025-12-30HUMAN PRESCRIPTION DRUG LABEL11