Prescription Drug Information: Pravastatin Sodium (Page 8 of 8)

Label — 40mg

Label 3
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Label — 80mg

Label4
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PRAVASTATIN SODIUM
pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-665(NDC:0093-0771)
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CROSPOVIDONE (15 MPA.S AT 5%)
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
SODIUM STEARYL FUMARATE
Product Characteristics
Color pink Score no score
Shape ROUND Size 7mm
Flavor Imprint Code TEVA;771
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-665-90 90 TABLET in 1 BOTTLE None
2 NDC:42291-665-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076056 06/30/2014
PRAVASTATIN SODIUM
pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-667(NDC:0093-7201)
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CROSPOVIDONE (15 MPA.S AT 5%)
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
CROSCARMELLOSE SODIUM
SODIUM STEARYL FUMARATE
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow (light-yellow) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code TEVA;7201
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-667-90 90 TABLET in 1 BOTTLE None
2 NDC:42291-667-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076056 06/30/2014
PRAVASTATIN SODIUM
pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-668(NDC:0093-7202)
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CROSPOVIDONE (15 MPA.S AT 5%)
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
CROSCARMELLOSE SODIUM
SODIUM STEARYL FUMARATE
FD&C BLUE NO. 1
D&C YELLOW NO. 10
Product Characteristics
Color green (light-green) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code TEVA;7202
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-668-90 90 TABLET in 1 BOTTLE None
2 NDC:42291-668-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076056 06/30/2014
PRAVASTATIN SODIUM
pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-669(NDC:0093-7270)
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CROSPOVIDONE (15 MPA.S AT 5%)
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
MAGNESIUM STEARATE
Product Characteristics
Color white (off-white to mottled grey) Score no score
Shape OVAL Size 18mm
Flavor Imprint Code TEVA;7270
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-669-90 90 TABLET in 1 BOTTLE None
2 NDC:42291-669-10 1000 TABLET in 1 BOTTLE None
3 NDC:42291-669-45 45 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077793 06/30/2014
Labeler — AvKARE (796560394)

Revised: 10/2021 AvKARE

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