PAROXETINE HYDROCHLORIDE

Product NDC

70518-1791

11-digit product format

705181791

Labeler code

70518

Product ID

70518-1791_99f2aace-606f-ad7a-e053-2995a90a5556

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

paroxetine hydrochloride

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

NDA020936

Marketing category

NDA

Marketing start

2019-01-11

Marketing end

0000-00-00

Substance

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Active strength

25 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