PRAVASTATIN SODIUM (Page 8 of 8)

10 mg, 90 ct Bottle Label
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20 mg, 90 ct Bottle Label
(click image for full-size original)
40 mg, 90 ct Bottle Label
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80 mg, 90 ct Bottle Label
(click image for full-size original)
PRAVASTATIN SODIUM pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-045
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM (PRAVASTATIN) PRAVASTATIN SODIUM 10 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM OXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color WHITE (white to off -White) Score no score
Shape RECTANGLE (Rounded, Rectangle) Size 7mm
Flavor Imprint Code B;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-045-11 30 TABLET in 1 BOTTLE None
2 NDC:70377-045-12 90 TABLET in 1 BOTTLE None
3 NDC:70377-045-14 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209869 02/01/2021
PRAVASTATIN SODIUM pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-046
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM (PRAVASTATIN) PRAVASTATIN SODIUM 20 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM OXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color WHITE (white to off -White) Score no score
Shape RECTANGLE (Rounded, Rectangle) Size 8mm
Flavor Imprint Code B;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-046-11 30 TABLET in 1 BOTTLE None
2 NDC:70377-046-12 90 TABLET in 1 BOTTLE None
3 NDC:70377-046-14 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209869 02/01/2021
PRAVASTATIN SODIUM pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-047
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM (PRAVASTATIN) PRAVASTATIN SODIUM 40 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM OXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color WHITE (white to off -White) Score no score
Shape RECTANGLE (Rounded, Rectangle) Size 10mm
Flavor Imprint Code B;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-047-11 30 TABLET in 1 BOTTLE None
2 NDC:70377-047-12 90 TABLET in 1 BOTTLE None
3 NDC:70377-047-14 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209869 02/01/2021
PRAVASTATIN SODIUM pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-048
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM (PRAVASTATIN) PRAVASTATIN SODIUM 80 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM OXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color WHITE (white to off -White) Score no score
Shape OVAL Size 17mm
Flavor Imprint Code B;80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-048-11 30 TABLET in 1 BOTTLE None
2 NDC:70377-048-12 90 TABLET in 1 BOTTLE None
3 NDC:70377-048-13 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209869 02/01/2021
Labeler — BIOCON PHARMA INC., (080000063)
Registrant — BIOCON PHARMA LIMITED (871412155)
Establishment
Name Address ID/FEI Operations
APPCO PHARMA LLC 078510186 manufacture (70377-045), manufacture (70377-046), manufacture (70377-047), manufacture (70377-048)

Revised: 07/2021 BIOCON PHARMA INC.,

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