PRAVASTATIN SODIUM - pravastatin sodium tablet 
Zydus Lifesciences Limited

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PRAVASTATIN SODIUM TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-739-05 in bottle of 500 tablets

Pravastatin Sodium Tablets USP, 10 mg

Rx only

500 tablets

Pravastatin Sodium Tablets USP, 10 mg

NDC 65841-740-05 in bottle of 500 tablets

Pravastatin Sodium Tablets USP, 20 mg

Rx only

500 tablets

Pravastatin Sodium Tablets USP, 20 mg

NDC 65841-741-05 in bottle of 500 tablets

Pravastatin Sodium Tablets USP, 40 mg

Rx only

500 tablets

Pravastatin Sodium Tablets, 40 mg

NDC 65841-742-05 in bottle of 500 tablets

Pravastatin Sodium Tablets USP, 80 mg

Rx only

500 tablets

Pravastatin Sodium Tablets, 80 mg
PRAVASTATIN SODIUM 
pravastatin sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-739
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G) PRAVASTATIN SODIUM10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVAL (OVAL) Size9mm
FlavorImprint Code ZC46
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-739-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
2NDC:65841-739-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07775103/30/2010
PRAVASTATIN SODIUM 
pravastatin sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-740
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G) PRAVASTATIN SODIUM20 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVAL (OVAL) Size11mm
FlavorImprint Code ZC45
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-740-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
2NDC:65841-740-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
3NDC:65841-740-101000 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07775103/30/2010
PRAVASTATIN SODIUM 
pravastatin sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-741
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G) PRAVASTATIN SODIUM40 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVAL (OVAL) Size14mm
FlavorImprint Code ZC44
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-741-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
2NDC:65841-741-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07775103/30/2010
PRAVASTATIN SODIUM 
pravastatin sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-742
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G) PRAVASTATIN SODIUM80 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVAL (OVAL) Size19mm
FlavorImprint Code ZC43
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-742-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
2NDC:65841-742-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07775103/30/2010
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited677605858ANALYSIS(65841-739, 65841-740, 65841-741, 65841-742) , MANUFACTURE(65841-739, 65841-740, 65841-741, 65841-742)

Revised: 10/2022
Document Id: 06a7213c-2672-47ba-86ec-58754a44504d
Set id: 187997be-2dbf-40af-885f-16df6ba9ae46
Version: 10
Effective Time: 20221013
 
Zydus Lifesciences Limited