ATORVASTATIN CALCIUM (Page 10 of 10)

Package/Label Display Panel

Atorvastatin Calcium

10 mg

100 Tablets
Carton label
(click image for full-size original)

Package/Label Display Panel

Atorvastatin Calcium

20 mg

100 Tablets

Carton label
(click image for full-size original)
ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6290(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
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
Hydroxypropyl Cellulose (1600000 WAMW)
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:0904-6290-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6290-61)
2 NDC:0904-6290-06 50 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6290-06)
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:0904-6291(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
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
Hydroxypropyl Cellulose (1600000 WAMW)
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:0904-6291-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6291-61)
2 NDC:0904-6291-06 50 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6291-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090548 05/29/2012
Labeler — Major Pharmaceuticals (191427277)

Revised: 03/2022 Major Pharmaceuticals

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