Statins
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Zypitamag Prescribing Information

Drug Detail:Zypitamag (Pitavastatin [ pit-av-a-stat-in ])

Drug Class: Statins

Contents
Uses Warnings Before Taking Dosage Side effects Interactions
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 Code877
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 Code878
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)

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