Paroxetine

Product NDC

52343-076

11-digit product format

523430076

Labeler code

52343

Product ID

52343-076_1a57b09e-842c-4f1b-91ca-03f0be9fe767

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Paroxetine Hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

ACETRIS HEALTH, LLC

Application

ANDA078406

Marketing category

ANDA

Marketing start

2007-07-25

Marketing end

2021-02-01

Substance

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Active strength

40 mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record