Paroxetine Hydrochloride

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Physicians Total Care, Inc.

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

54868-6178

Application Number

ANDA077873

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 9, 2011

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

ParoxetineActive

Code: 3I3T11UD2SClass: ACTIMQuantity: 12.5 mg in 1 1

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

POLYDEXTROSEInactive

Code: VH2XOU12IEClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8JClass: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1AClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT