Paroxetine Hydrochloride
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, USP, for oral use Initial U.S. Approval: 1992
Approved
Approval ID
f22886f5-230c-47e4-9dd8-ffb14c8d6ae4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2023
Manufacturers
FDA
Lannett Company, Inc.
DUNS: 006422406
Products 3
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 Code62175-471
Application NumberANDA204744
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2021
FDA Product Classification
INGREDIENTS (14)
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
PAROXETINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)Inactive
Code: T967IEU43C
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PIGMENT RED 48Inactive
Code: 07XHK4SAV6
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYVINYL ALCOHOL (100000 MW)Inactive
Code: 949E52Z6MY
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Paroxetine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62175-472
Application NumberANDA204744
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2021
FDA Product Classification
INGREDIENTS (13)
PAROXETINE HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)Inactive
Code: T967IEU43C
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOL (100000 MW)Inactive
Code: 949E52Z6MY
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Paroxetine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62175-470
Application NumberANDA204744
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2021
FDA Product Classification
INGREDIENTS (12)
PAROXETINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)Inactive
Code: T967IEU43C
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL (100000 MW)Inactive
Code: 949E52Z6MY
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT