PAROXETINE HYDROCHLORIDE

Product NDC

63629-4615

11-digit product format

636294615

Labeler code

63629

Product ID

63629-4615_4c7ed1cf-75c6-461d-8bda-17955dadb43c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

paroxetine hydrochloride

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Bryant Ranch Prepack

Application

NDA020936

Marketing category

NDA

Marketing start

2010-09-13

Marketing end

0000-00-00

Substance

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Active strength

13 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