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
555cfa31-3865-450f-b16b-2f4004af7a67
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2023
Manufacturers
FDA
Modavar Pharmaceuticals LLC
DUNS: 858949204
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Paroxetine
PRODUCT DETAILS
NDC Product Code72241-029
Application NumberANDA212645
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 19, 2023
Generic NameParoxetine
INGREDIENTS (15)
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 12.5 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
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
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Paroxetine
PRODUCT DETAILS
NDC Product Code72241-030
Application NumberANDA212645
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 19, 2023
Generic NameParoxetine
INGREDIENTS (15)
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 25 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
Paroxetine
PRODUCT DETAILS
NDC Product Code72241-031
Application NumberANDA212645
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 19, 2023
Generic NameParoxetine
INGREDIENTS (15)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 37.5 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT