NDC Code(s) : 54569-4466-0, 54569-4466-1, 54569-4466-2, 54569-4467-0, 54569-4467-1, 54569-4587-0, 54569-4587-1, 54569-5382-0, 54569-5382-1
Packager : A-S Medication Solutions LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lipitoratorvastatin calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-4466(NDC:0071-0155)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN CALCIUM10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CANDELILLA WAX(UNII: WL0328HX19)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSE(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color WHITE Score no score
Shape OVAL (elliptical) Size 10 mm
Flavor Imprint Code PD;155;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-4466-030 in 1 BOTTLE, DISPENSING
2NDC:54569-4466-1100 in 1 BOTTLE, DISPENSING
3NDC:54569-4466-290 in 1 BOTTLE, DISPENSING
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020702 03/11/1997
Lipitoratorvastatin calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-4467(NDC:0071-0156)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN CALCIUM20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CANDELILLA WAX(UNII: WL0328HX19)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSE(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color WHITE Score no score
Shape OVAL (elliptical) Size 12 mm
Flavor Imprint Code PD;156;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-4467-030 in 1 BOTTLE, DISPENSING
2NDC:54569-4467-190 in 1 BOTTLE, DISPENSING
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020702 03/11/1997
Lipitoratorvastatin calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-4587(NDC:0071-0157)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN CALCIUM40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CANDELILLA WAX(UNII: WL0328HX19)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSE(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color WHITE Score no score
Shape OVAL (elliptical) Size 15 mm
Flavor Imprint Code PD;157;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-4587-030 in 1 BOTTLE, DISPENSING
2NDC:54569-4587-190 in 1 BOTTLE, DISPENSING
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020702 06/08/1998
Lipitoratorvastatin calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-5382(NDC:0071-0158)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN CALCIUM80 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CANDELILLA WAX(UNII: WL0328HX19)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSE(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color WHITE Score no score
Shape OVAL (elliptical) Size 19 mm
Flavor Imprint Code PD;158;80
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-5382-030 in 1 BOTTLE, DISPENSING
2NDC:54569-5382-190 in 1 BOTTLE, DISPENSING
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020702 04/08/2002

PRINCIPAL DISPLAY PANEL

Lipitor 10 mg LabelLipitor 10 mg LabelLipitor 10 mg LabelLipitor 10 mg Label