ATORVASTATIN CALCIUM (Page 11 of 11)

PACKAGE LABEL

Label Image for 53808-0959
10mg

Label Image for 10mgLabel Image for 10mg

PACKAGE LABEL

Label Image for 53808-1035 40mg

Label Image for 40mgLabel Image for 40mg
ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-0959(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
COLLOIDAL 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:53808-0959-1 30 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090548 01/01/2014
ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-1035(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
COLLOIDAL 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:53808-1035-1 30 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090548 01/01/2014
Labeler — State of Florida DOH Central Pharmacy (829348114)
Establishment
Name Address ID/FEI Operations
State of Florida DOH Central Pharmacy 829348114 repack (53808-0959), repack (53808-1035)

Revised: 11/2014 State of Florida DOH Central Pharmacy

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