NDC Code(s) : 43063-474-30, 43063-474-90
Packager : PD-Rx Pharmaceuticals, Inc.

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:43063-474(NDC:60505-2578)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE(UNII: YRZ789OWMI)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM ACETATE(UNII: Y882YXF34X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SODIUM CARBONATE(UNII: 45P3261C7T)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score no score
Shape OVAL Size 9 mm
Flavor Imprint Code APO;A10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43063-474-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product29/05/2012
2NDC:43063-474-9090 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product29/05/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090548 05/29/2012

LABELER - PD-Rx Pharmaceuticals, Inc.(156893695)

REGISTRANT - PD-Rx Pharmaceuticals, Inc.(156893695)

Establishment
Name Address ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-474)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 10 mg BOTTLE LABEL

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

Atorvastatin Calcium Tablets

10 mg

Rx

43063474 Label