PAXIL

These highlights do not include all the information needed to use PAXIL CR safely and effectively. See full prescribing information for PAXIL CR. PAXIL CR(paroxetine) extended-release Tablets, for oral use Initial U.S. Approval: 1992

Approved

Approval ID

483bd97f-c4d0-4e23-aaa8-6334f4471e0c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 10, 2024

Manufacturers

FDA

Apotex Corp

DUNS: 845263701

Products 6

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

paroxetine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code60505-3670

Application NumberNDA020936

Product Classification

Marketing Category

C73594

Generic Name

paroxetine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 10, 2024

FDA Product Classification

INGREDIENTS (16)

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

PAROXETINE HYDROCHLORIDEActive

Quantity: 37.5 mg in 1 1

Code: X2ELS050D8

Classification: ACTIM

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

POLYETHYLENE GLYCOL 10000Inactive

Code: H57W405143

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

paroxetine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code60505-3669

Application NumberNDA020936

Product Classification

Marketing Category

C73594

Generic Name

paroxetine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 10, 2024

FDA Product Classification

INGREDIENTS (16)

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

PAROXETINE HYDROCHLORIDEActive

Quantity: 25 mg in 1 1

Code: X2ELS050D8

Classification: ACTIM

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 10000Inactive

Code: H57W405143

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

paroxetine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code60505-3668

Application NumberNDA020936

Product Classification

Marketing Category

C73594

Generic Name

paroxetine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 10, 2024

FDA Product Classification

INGREDIENTS (16)

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

PAROXETINE HYDROCHLORIDEActive

Quantity: 12.5 mg in 1 1

Code: X2ELS050D8

Classification: ACTIM

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

POLYETHYLENE GLYCOL 10000Inactive

Code: H57W405143

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

paroxetine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code60505-4379

Application NumberNDA020936

Product Classification

Marketing Category

C73594

Generic Name

paroxetine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 10, 2024

FDA Product Classification

INGREDIENTS (16)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

PAROXETINE HYDROCHLORIDEActive

Quantity: 37.5 mg in 1 1

Code: X2ELS050D8

Classification: ACTIM

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 10000Inactive

Code: H57W405143

Classification: IACT

paroxetine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code60505-4377

Application NumberNDA020936

Product Classification

Marketing Category

C73594

Generic Name

paroxetine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 10, 2024

FDA Product Classification

INGREDIENTS (17)

PAROXETINE HYDROCHLORIDEActive

Quantity: 12.5 mg in 1 1

Code: X2ELS050D8

Classification: ACTIM

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

POLYETHYLENE GLYCOL 10000Inactive

Code: H57W405143

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

paroxetine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code60505-4378

Application NumberNDA020936

Product Classification

Marketing Category

C73594

Generic Name

paroxetine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 10, 2024

FDA Product Classification

INGREDIENTS (16)

PAROXETINE HYDROCHLORIDEActive

Quantity: 25 mg in 1 1

Code: X2ELS050D8

Classification: ACTIM

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

POLYETHYLENE GLYCOL 10000Inactive

Code: H57W405143

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

D&C RED NO. 30Inactive

Code: 2S42T2808B

Classification: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

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PAXIL

Products 6

paroxetine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

paroxetine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

paroxetine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

paroxetine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

paroxetine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

paroxetine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

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