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, for oral use Initial U.S. Approval: 2009
Approved
Approval ID
9ad1ecb9-822d-47c1-9f6f-6f771fa0f924
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2023
Manufacturers
FDA
Upsher-Smith Laboratories, LLC
DUNS: 047251004
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 Code0832-6049
Application NumberANDA205955
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pitavastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (9)
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Pitavastatin CalciumActive
Quantity: 2 mg in 1 1
Code: IYD54XEG3W
Classification: ACTIM
Magnesium CarbonateInactive
Code: 0E53J927NA
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Pitavastatin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0832-6050
Application NumberANDA205955
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pitavastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (9)
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium CarbonateInactive
Code: 0E53J927NA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Pitavastatin CalciumActive
Quantity: 4 mg in 1 1
Code: IYD54XEG3W
Classification: ACTIM
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Pitavastatin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0832-6048
Application NumberANDA205955
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pitavastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 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
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium CarbonateInactive
Code: 0E53J927NA
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT