PAXIL
These highlights do not include all the information needed to use PAXIL safely and effectively. See full prescribing information for PAXIL. PAXIL (paroxetine) tablets, for oral use PAXIL (paroxetine) oral suspensionInitial U.S. Approval: 1992
Approved
Approval ID
ef3b5cbe-f9e1-c1ac-79da-cfe14e3a7e7e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 25, 2023
Manufacturers
FDA
Apotex Corp
DUNS: 845263701
Products 4
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 Code60505-4517
Application NumberNDA020031
Product Classification
M
Marketing Category
C73594
G
Generic Name
paroxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 25, 2023
FDA Product Classification
INGREDIENTS (10)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PAROXETINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE B POTATOInactive
Code: 27NA468985
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
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 Code60505-4520
Application NumberNDA020031
Product Classification
M
Marketing Category
C73594
G
Generic Name
paroxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 25, 2023
FDA Product Classification
INGREDIENTS (10)
SODIUM STARCH GLYCOLATE TYPE B POTATOInactive
Code: 27NA468985
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
PAROXETINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
paroxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-4519
Application NumberNDA020031
Product Classification
M
Marketing Category
C73594
G
Generic Name
paroxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 25, 2023
FDA Product Classification
INGREDIENTS (9)
PAROXETINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE B POTATOInactive
Code: 27NA468985
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
paroxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-4518
Application NumberNDA020031
Product Classification
M
Marketing Category
C73594
G
Generic Name
paroxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 25, 2023
FDA Product Classification
INGREDIENTS (9)
PAROXETINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE B POTATOInactive
Code: 27NA468985
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT