PAROXETINE
Paroxetine Tablets, USP These highlights do not include all the information needed to use PAROXETINE TABLETS, USP safely and effectively. See full prescribing information for PAROXETINE TABLETS, USP. PAROXETINE tablets, USP, for oral use Initial U.S. Approval: 1992
Approved
Approval ID
69699d40-4a64-4337-8664-e4e093437fbf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2023
Manufacturers
FDA
Chartwell RX, LLC.
DUNS: 079394054
Products 4
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 Code62135-542
Application NumberANDA211248
Product Classification
M
Marketing Category
C73584
G
Generic Name
PAROXETINE
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2023
FDA Product Classification
INGREDIENTS (8)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 20 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
PAROXETINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-541
Application NumberANDA211248
Product Classification
M
Marketing Category
C73584
G
Generic Name
PAROXETINE
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2023
FDA Product Classification
INGREDIENTS (13)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 10 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
PAROXETINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-543
Application NumberANDA211248
Product Classification
M
Marketing Category
C73584
G
Generic Name
PAROXETINE
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2023
FDA Product Classification
INGREDIENTS (9)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 30 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
PAROXETINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-544
Application NumberANDA211248
Product Classification
M
Marketing Category
C73584
G
Generic Name
PAROXETINE
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2023
FDA Product Classification
INGREDIENTS (12)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 40 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 3/15/2023