Sertraline

Product NDC

0143-9654

11-digit product format

001439654

Labeler code

0143

Product ID

0143-9654_e9e5e153-4b47-4297-9b92-7b175eafcac5

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

sertraline hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Hikma Pharmaceuticals USA Inc.

Application

ANDA077864

Marketing category

ANDA

Marketing start

2012-11-06

Marketing end

0000-00-00

Substance

SERTRALINE HYDROCHLORIDE

Active strength

100 mg/1

Pharmacologic classes

Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record