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 use Initial U.S. Approval: 2009
Approved
Approval ID
7b1a9aa6-a7a4-4050-8a40-89ba9728555a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
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 Code70771-1786
Application NumberANDA206047
Product Classification
M
Marketing Category
C73584
G
Generic Name
pitavastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (10)
PITAVASTATIN CALCIUMActive
Quantity: 4 mg in 1 1
Code: IYD54XEG3W
Classification: ACTIM
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
pitavastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1784
Application NumberANDA206047
Product Classification
M
Marketing Category
C73584
G
Generic Name
pitavastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (10)
PITAVASTATIN CALCIUMActive
Quantity: 1 mg in 1 1
Code: IYD54XEG3W
Classification: ACTIM
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
pitavastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1785
Application NumberANDA206047
Product Classification
M
Marketing Category
C73584
G
Generic Name
pitavastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (10)
PITAVASTATIN CALCIUMActive
Quantity: 2 mg in 1 1
Code: IYD54XEG3W
Classification: ACTIM
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT