PAXIL
These highlights do not include all the information needed to use PAXILsafely and effectively. See full prescribing information for PAXIL. PAXIL (paroxetine) tablets, for oral usePAXIL (paroxetine) oral suspensionInitial U.S. Approval: 1992
Approved
Approval ID
584ace29-6e40-432f-950f-ab7e98653d32
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2023
Manufacturers
FDA
Apotex Corp
DUNS: 845263701
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
paroxetine hydrochloride
PRODUCT DETAILS
NDC Product Code60505-3666
Application NumberNDA020031
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJanuary 18, 2023
Generic Nameparoxetine hydrochloride
INGREDIENTS (7)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
PAROXETINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
paroxetine hydrochloride
PRODUCT DETAILS
NDC Product Code60505-0402
Application NumberNDA020710
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJanuary 18, 2023
Generic Nameparoxetine hydrochloride
INGREDIENTS (13)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PAROXETINE HYDROCHLORIDEActive
Quantity: 10 mg in 5 mL
Code: X2ELS050D8
Classification: ACTIM
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
DIMETHICONE 410Inactive
Code: TYU5GP6XGE
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SACCHARIN SODIUM ANHYDROUSInactive
Code: I4807BK602
Classification: IACT