Atorvastatin Calcium (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72789084 Label
(click image for full-size original)

ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-084(NDC:72205-023)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
TALC
POLYETHYLENE GLYCOL 3350
CALCIUM CARBONATE
MAGNESIUM ALUMINOMETASILICATE TYPE I-A
LECITHIN, SOYBEAN
Product Characteristics
Color white Score no score
Shape OVAL Size 12mm
Flavor Imprint Code MA;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-084-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211933 02/08/2019
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (72789-084)

Revised: 05/2020 PD-Rx Pharmaceuticals, Inc.

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