FDA Product

Paroxetine

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Paroxetine

FDA Product Code

71205-527

Regulatory Information

NDC Product Code

71205-527

Application Number

ANDA203854

Marketing Category

C73584

Effective Date

January 1, 2021

Territorial Authority

USA

FDA Title

Paroxetine Tablets USP, film coated for oral use

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerProficient Rx LP

DUNS Number

079196022

Active Ingredients

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Quantity: 10 mg in 1 1

Code: X2ELS050D8

Class Code: ACTIM

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

GLYCERYL DIBEHENATE

Code: R8WTH25YS2

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

Active Moieties

PAROXETINE

Code: 41VRH5220H

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