ATORVASTATIN CALCIUM (Page 10 of 10)

Atorvastatin Calcium Tablets 10mg

Atorvastatin Calcium Tablets 10 mg
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Atorvastatin Calcium Tablets 20mg

Atorvastatin Calcium Tablets 20mg
(click image for full-size original)

Atorvastatin Calcium Tablets 40 mg

Atorvastatin Calcium Tablets 40 mg
(click image for full-size original)
ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70882-109(NDC:60505-2580)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE (ATORVASTATIN) ATORVASTATIN 40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM ACETATE
CROSCARMELLOSE SODIUM
SODIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSES
HYDROXYPROPYL CELLULOSE (TYPE H)
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 14mm
Flavor Imprint Code APO;ATV40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70882-109-30 30 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090548 05/29/2012
ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70882-119(NDC:60505-2578)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE (ATORVASTATIN) ATORVASTATIN 10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM ACETATE
CROSCARMELLOSE SODIUM
SODIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSES
HYDROXYPROPYL CELLULOSE (TYPE H)
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 9mm
Flavor Imprint Code APO;A10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70882-119-30 30 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090548 05/29/2012
ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70882-120(NDC:60505-2579)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE (ATORVASTATIN) ATORVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM ACETATE
CROSCARMELLOSE SODIUM
SODIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSES
HYDROXYPROPYL CELLULOSE (TYPE H)
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 11mm
Flavor Imprint Code APO;ATV20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70882-120-30 30 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090548 05/29/2012
Labeler — Cambridge Therapeutics Technologies, LLC (080072003)

Revised: 06/2017 Cambridge Therapeutics Technologies, LLC

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