Sertraline Hydrochloride

Product NDC
72162-2407
11-digit product format
721622407
Labeler code
72162
Product ID
72162-2407_71094aa2-232a-452f-b92a-47ccab669523
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077206
Marketing category
ANDA
Marketing start
2007-02-06
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2407-37216224070330 TABLET, FILM COATED in 1 BOTTLE (72162-2407-3) 2024-10-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Sertraline HydrochlorideBryant Ranch Prepack2024-10-21HUMAN PRESCRIPTION DRUG LABEL100