Pitavastatin
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, film coated for oral use. Initial U.S. Approval: 2009
Approved
Approval ID
fac09182-dcf2-1770-e053-6394a90af50c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2023
Manufacturers
FDA
Teva Pharmaceuticals, Inc.
DUNS: 022629579
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pitavastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0480-3633
Application NumberANDA205932
Product Classification
M
Marketing Category
C73584
G
Generic Name
pitavastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2023
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PITAVASTATIN CALCIUMActive
Quantity: 4.18 mg in 1 1
Code: IYD54XEG3W
Classification: ACTIM
pitavastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0480-3631
Application NumberANDA205932
Product Classification
M
Marketing Category
C73584
G
Generic Name
pitavastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2023
FDA Product Classification
INGREDIENTS (11)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
PITAVASTATIN CALCIUMActive
Quantity: 1.045 mg in 1 1
Code: IYD54XEG3W
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
pitavastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0480-3632
Application NumberANDA205932
Product Classification
M
Marketing Category
C73584
G
Generic Name
pitavastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2023
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
PITAVASTATIN CALCIUMActive
Quantity: 2.09 mg in 1 1
Code: IYD54XEG3W
Classification: ACTIM