NDC Code(s) : 63629-3366-1, 63629-3366-2, 63629-3366-3, 63629-3366-4, 63629-3366-5
Packager : Bryant Ranch Prepack

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:63629-3366(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) 		ATORVASTATIN80 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)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS(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:63629-3366-130 in 1 BOTTLE
2NDC:63629-3366-260 in 1 BOTTLE
3NDC:63629-3366-3100 in 1 BOTTLE
4NDC:63629-3366-4180 in 1 BOTTLE
5NDC:63629-3366-590 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020702 04/07/2000

PRINCIPAL DISPLAY PANEL

Label