NDC Code(s) : 50090-6604-0, 50090-6604-1, 50090-6604-2
Packager : A-S Medication Solutions

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:50090-6604(NDC:50228-452)
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
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
COPOVIDONE K25-31(UNII: D9C330MD8B)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
SODIUM CARBONATE(UNII: 45P3261C7T)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 12 mm
Flavor Imprint Code SG;153
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-6604-030 in 1 BOTTLE Type 0: Not a Combination Product22/08/2023
2NDC:50090-6604-190 in 1 BOTTLE Type 0: Not a Combination Product22/08/2023
3NDC:50090-6604-2100 in 1 BOTTLE Type 0: Not a Combination Product22/08/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205519 05/19/2016

LABELER - A-S Medication Solutions(830016429)

Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-6604), REPACK(50090-6604)

PRINCIPAL DISPLAY PANEL

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