Pitavastatin Calcium
These highlights do not include all the information needed to use PITAVASTATIN TABLETS safely and effectively. See full prescribing information for PITAVASTATIN TABLETS. PITAVASTATIN tablets, for oral useInitial U.S. Approval: 2009
Approved
Approval ID
26b5e5e8-45cd-4a98-9af4-2d04c1130881
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2023
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pitavastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-5057
Application NumberANDA206070
Product Classification
M
Marketing Category
C73584
G
Generic Name
pitavastatin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PITAVASTATIN CALCIUMActive
Quantity: 4 mg in 1 1
Code: IYD54XEG3W
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
pitavastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-5055
Application NumberANDA206070
Product Classification
M
Marketing Category
C73584
G
Generic Name
pitavastatin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (9)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
PITAVASTATIN CALCIUMActive
Quantity: 1 mg in 1 1
Code: IYD54XEG3W
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
pitavastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-5056
Application NumberANDA206070
Product Classification
M
Marketing Category
C73584
G
Generic Name
pitavastatin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (9)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PITAVASTATIN CALCIUMActive
Quantity: 2 mg in 1 1
Code: IYD54XEG3W
Classification: ACTIM
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT