NDC Code(s) : 72789-084-30
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:72789-084(NDC:72205-023)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN20 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
CALCIUM CARBONATE(UNII: H0G9379FGK)
MAGNESIUM ALUMINOMETASILICATE TYPE I-A(UNII: 7LVU907546)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
Product Characteristics
Color white Score no score
Shape OVAL Size 12 mm
Flavor Imprint Code MA;2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72789-084-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/05/2020
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 Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack(72789-084)

PRINCIPAL DISPLAY PANEL

image