Paroxetine
These highlights do not include all the information needed to use PAROXETINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PAROXETINE EXTENDED-RELEASE TABLETS. PAROXETINE extended-release tablets, for oral use Initial U.S. Approval: 1992
Approved
Approval ID
f39a2a7a-7a7e-4dd8-9704-54d9598504fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2023
Manufacturers
FDA
Westminster Pharmaceuticals, LLC
DUNS: 079516651
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Paroxetine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69367-336
Application NumberANDA213485
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (16)
PAROXETINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
Paroxetine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69367-337
Application NumberANDA213485
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (15)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
PAROXETINE HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
Paroxetine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69367-335
Application NumberANDA213485
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (18)
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
PAROXETINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT