PITAVASTATIN CALCIUM- pitavastatin calcium tablet 
Zydus Lifesciences Limited

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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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pitavastatin Tablets, 1 mg

NDC 70771-1784-9

Bottle of 90 tablets

Rx only

1 mg label

Pitavastatin Tablets, 2 mg

NDC 70771-1785-9

Bottle of 90 tablets

Rx only

2 mg label

Pitavastatin Tablets, 4 mg

NDC 70771-1786-9

Bottle of 90 tablets

Rx only

4 mg label
PITAVASTATIN CALCIUM 
pitavastatin calcium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1784
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PITAVASTATIN CALCIUM (UNII: IYD54XEG3W) (PITAVASTATIN - UNII:M5681Q5F9P) PITAVASTATIN1 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code 481
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1784-990 in 1 BOTTLE; Type 0: Not a Combination Product11/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20604711/02/2023
PITAVASTATIN CALCIUM 
pitavastatin calcium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1785
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PITAVASTATIN CALCIUM (UNII: IYD54XEG3W) (PITAVASTATIN - UNII:M5681Q5F9P) PITAVASTATIN2 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code 482
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1785-990 in 1 BOTTLE; Type 0: Not a Combination Product11/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20604711/02/2023
PITAVASTATIN CALCIUM 
pitavastatin calcium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1786
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PITAVASTATIN CALCIUM (UNII: IYD54XEG3W) (PITAVASTATIN - UNII:M5681Q5F9P) PITAVASTATIN4 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size9mm
FlavorImprint Code 483
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1786-990 in 1 BOTTLE; Type 0: Not a Combination Product11/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20604711/02/2023
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1784, 70771-1785, 70771-1786) , MANUFACTURE(70771-1784, 70771-1785, 70771-1786)

Revised: 11/2023
Document Id: 5f0f2de1-374e-449c-8796-aab39f1eb0bd
Set id: 7b1a9aa6-a7a4-4050-8a40-89ba9728555a
Version: 4
Effective Time: 20231103
 
Zydus Lifesciences Limited