NDC Code(s) : 68788-7525-3, 68788-7525-6, 68788-7525-9, 68788-7525-1
Packager : Preferred 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:68788-7525(NDC:67877-513)
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
MICROCRYSTALLINE CELLULOSE 101(UNII: 7T9FYH5QMK)
CALCIUM CARBONATE(UNII: H0G9379FGK)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (110000 WAMW)(UNII: 5Y0974F5PW)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score no score
Shape OVAL (elliptical) Size 15 mm
Flavor Imprint Code 40;ATS
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68788-7525-390 in 1 BOTTLE Type 0: Not a Combination Product13/03/2020
2NDC:68788-7525-6500 in 1 BOTTLE Type 0: Not a Combination Product13/03/2020
3NDC:68788-7525-91000 in 1 BOTTLE Type 0: Not a Combination Product13/03/2020
4NDC:68788-7525-12000 in 1 BOTTLE Type 0: Not a Combination Product13/03/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209288 03/13/2020

LABELER - Preferred Pharmaceuticals Inc.(791119022)

REGISTRANT - Preferred Pharmaceuticals Inc.(791119022)

Establishment
Name Address ID/FEI Business Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-7525)

PRINCIPAL DISPLAY PANEL

  Atorvastatin Calcium Tablets 40mg

Atorvastatin Caclium Tablets, USP 40 mg

NDC 68788-7525