Paroxetine

Basic Information

Product Name

Paroxetine

FDA Product Code

68382-098

Regulatory Information

NDC Product Code

68382-098

Application Number

ANDA077584

Marketing Category

C73584

Effective Date

September 28, 2023

Territorial Authority

USA

FDA Title

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Quantity: 20 mg in 1 1

Code: X2ELS050D8

Class Code: ACTIM

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Code: L11K75P92J

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

POLYETHYLENE GLYCOL 6000

Code: 30IQX730WE

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

Active Moieties

Code: 41VRH5220H

Paroxetine

Basic Information

Regulatory Information

Company Information

Active Ingredients

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

HYPROMELLOSES

MAGNESIUM STEARATE

ANHYDROUS LACTOSE

POLYETHYLENE GLYCOL 6000

SODIUM STARCH GLYCOLATE TYPE A POTATO

TALC

TITANIUM DIOXIDE

POVIDONE

Active Moieties

PAROXETINE