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
42291-906Application Number
ANDA205932Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 16, 2024LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
PitavastatinActive
Code: IYD54XEG3WClass: ACTIMQuantity: 2.09 mg in 1 1
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71GClass: IACT
Pitavastatin
Product Details
NDC Product Code
42291-905Application Number
ANDA205932Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 16, 2024CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71GClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
PitavastatinActive
Code: IYD54XEG3WClass: ACTIMQuantity: 1.045 mg in 1 1
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
Pitavastatin
Product Details
NDC Product Code
42291-907Application Number
ANDA205932Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 16, 2024LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71GClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
PitavastatinActive
Code: IYD54XEG3WClass: ACTIMQuantity: 4.18 mg in 1 1