Paroxetine
Approved
Approval ID
0fb2e3cc-b9b5-48a6-b487-1e558dfd56db
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 12, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Paroxetine hydrochloride hemihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0393
Application NumberANDA078902
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine hydrochloride hemihydrate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2010
FDA Product Classification
INGREDIENTS (13)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 10 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Paroxetine hydrochloride hemihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0394
Application NumberANDA078902
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine hydrochloride hemihydrate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2010
FDA Product Classification
INGREDIENTS (13)
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 20 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Paroxetine hydrochloride hemihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0601
Application NumberANDA078902
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine hydrochloride hemihydrate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2010
FDA Product Classification
INGREDIENTS (13)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 30 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Paroxetine hydrochloride hemihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0655
Application NumberANDA078902
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine hydrochloride hemihydrate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2010
FDA Product Classification
INGREDIENTS (13)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 40 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT