Basic Information
Atorvastatin Calcium
42708-003
Regulatory Information
42708-003
ANDA205300
C73584
August 11, 2023
USA
These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
HUMAN PRESCRIPTION DRUG LABEL
6
Company Information
030620888
Active Ingredients
CALCIUM CARBONATE
Code: H0G9379FGK
Class Code: IACT
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)
Code: 5Y0974F5PW
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
HYPROMELLOSE 2910 (6 MPA.S)
Code: 0WZ8WG20P6
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
POLYETHYLENE GLYCOL 6000
Code: 30IQX730WE
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
POLYSORBATE 80
Code: 6OZP39ZG8H
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
Active Moieties
ATORVASTATIN
Code: A0JWA85V8F