Atorvastatin calcium tablet, film coated

Ingredients and appearance - Product information

Atorvastatin calcium tablet, film coated- Atorvastatin calcium

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0440-7128
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Atorvastatin calcium propylene glycol solvate ( UNII: YRZ789OWMI)( Atorvastatin - UNII: A0JWA85V8F ) 80 mgin 1

Inactive Ingredients

Ingredient Name Code
Calcium acetate ( UNII: Y882YXF34X)
Croscarmellose sodium ( UNII: M28OL1HH48)
Sodium carbonate ( UNII: 45P3261C7T)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Magnesium stearate ( UNII: 70097M6I30)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Hypromelloses ( UNII: 3NXW29V3WO)
Hydroxypropyl cellulose (type h) ( UNII: RFW2ET671P)
Polyethylene glycol 8000 ( UNII: Q662QK8M3B)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color WHITE Imprint Code APO;ATV80
Score 1 Shape OVAL
Size 19 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0440-7128-30 30 in 1 BOTTLE 2012/05/29
2 NDC: 0440-7128-60 60 in 1 BOTTLE 2012/05/29
3 NDC: 0440-7128-81 300 in 1 BOTTLE 2012/05/29
4 NDC: 0440-7128-85 800 in 1 BOTTLE 2012/05/29
5 NDC: 0440-7128-90 90 in 1 BOTTLE 2012/05/29

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA090548 USA 2012/05/29

Labeler - Liberty Pharmaceuticals, Inc.( 012568840)