Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pitavastatin
Product Details
NDC Product Code
0832-6049Application Number
ANDA205955Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 31, 2023Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT
PitavastatinActive
Code: IYD54XEG3WClass: ACTIMQuantity: 2 mg in 1 1
Magnesium CarbonateInactive
Code: 0E53J927NAClass: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5XClass: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
Pitavastatin
Product Details
NDC Product Code
0832-6050Application Number
ANDA205955Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 31, 2023Lactose MonohydrateInactive
Code: EWQ57Q8I5XClass: IACT
Magnesium CarbonateInactive
Code: 0E53J927NAClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
PitavastatinActive
Code: IYD54XEG3WClass: ACTIMQuantity: 4 mg in 1 1
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT
Pitavastatin
Product Details
NDC Product Code
0832-6048Application Number
ANDA205955Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 31, 2023LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14Class: IACT
PitavastatinActive
Code: IYD54XEG3WClass: ACTIMQuantity: 1 mg in 1 1
Lactose MonohydrateInactive
Code: EWQ57Q8I5XClass: IACT
Magnesium CarbonateInactive
Code: 0E53J927NAClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT