Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PAXIL
Product Details
NDC Product Code
60505-4517Application Number
NDA020031Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 25, 2023DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ParoxetineActive
Code: X2ELS050D8Class: ACTIMQuantity: 10 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE B POTATOInactive
Code: 27NA468985Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
PAXIL
Product Details
NDC Product Code
60505-4520Application Number
NDA020031Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 25, 2023SODIUM STARCH GLYCOLATE TYPE B POTATOInactive
Code: 27NA468985Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
ParoxetineActive
Code: X2ELS050D8Class: ACTIMQuantity: 40 mg in 1 1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
PAXIL
Product Details
NDC Product Code
60505-4519Application Number
NDA020031Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 25, 2023ParoxetineActive
Code: X2ELS050D8Class: ACTIMQuantity: 30 mg in 1 1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
SODIUM STARCH GLYCOLATE TYPE B POTATOInactive
Code: 27NA468985Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
PAXIL
Product Details
NDC Product Code
60505-4518Application Number
NDA020031Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 25, 2023ParoxetineActive
Code: X2ELS050D8Class: ACTIMQuantity: 20 mg in 1 1
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
SODIUM STARCH GLYCOLATE TYPE B POTATOInactive
Code: 27NA468985Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808BClass: IACT