NDC Code(s) : 69189-3952-1
Packager : Avera McKennan Hospital

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Atorvastatin Calciumatorvastatin calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-3952(NDC:0378-3952)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN40 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SODIUM CARBONATE(UNII: 45P3261C7T)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYVINYL ALCOHOL(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
XANTHAN GUM(UNII: TTV12P4NEE)
ARGININE(UNII: 94ZLA3W45F)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code 40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69189-3952-11 in 1 DOSE PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091226 03/02/2015

PRINCIPAL DISPLAY PANEL

Atorvastatin 40 mg tablet label