Sertraline

Product NDC

57297-351

11-digit product format

572970351

Labeler code

57297

Product ID

57297-351_eb14d261-675a-418d-a62d-81453d423180

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Sertraline

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

LUPIN LIMITED

Application

ANDA077670

Marketing category

ANDA

Marketing start

2007-02-06

Marketing end

0000-00-00

Substance

SERTRALINE HYDROCHLORIDE

Active strength

25 mg/1

Pharmacologic classes

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

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record