ZYPITAMAG- pitavastatin magnesium tablet, film coated 
Zydus Lifesciences Limited

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ZYPITAMAG (pitavastatin) tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1117-9

Zypitamag (Pitavastatin) Tablets, 2 mg

90 Tablets

Rx only

image

NDC 70771-1118-9

Zypitamag (Pitavastatin) Tablets, 4 mg

90 Tablets

Rx only

image
ZYPITAMAG 
pitavastatin magnesium tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1117
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PITAVASTATIN (UNII: M5681Q5F9P) (PITAVASTATIN - UNII:M5681Q5F9P) PITAVASTATIN2 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (off white) Scoreno score
ShapeROUNDSize7mm
FlavorImprint Code 877
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1117-330 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
2NDC:70771-1117-990 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
3NDC:70771-1117-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
4NDC:70771-1117-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
5NDC:70771-1117-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
6NDC:70771-1117-410 in 1 CARTON03/09/2018
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:70771-1117-71 in 1 CARTON03/09/2018
77 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20837903/09/2018
ZYPITAMAG 
pitavastatin magnesium tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1118
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PITAVASTATIN (UNII: M5681Q5F9P) (PITAVASTATIN - UNII:M5681Q5F9P) PITAVASTATIN4 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (off white) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code 878
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1118-330 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
2NDC:70771-1118-990 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
3NDC:70771-1118-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
4NDC:70771-1118-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
5NDC:70771-1118-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
6NDC:70771-1118-410 in 1 CARTON03/09/2018
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:70771-1118-71 in 1 CARTON03/09/2018
77 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20837903/09/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1117, 70771-1118) , MANUFACTURE(70771-1117, 70771-1118)

Revised: 8/2024
Document Id: 8eab99e7-f5e0-4b8a-8cc6-2d90618ebf93
Set id: e9f0fe3a-0462-4c24-8f22-3c89afe8fcea
Version: 8
Effective Time: 20240814
 
Zydus Lifesciences Limited