ATORVASTATIN CALCIUM
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
Approved
Approval ID
77675dc3-868d-42a3-a179-80372a23e0c8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 21, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ATORVASTATIN CALCIUM
PRODUCT DETAILS
NDC Product Code50090-6506
Application NumberANDA090548
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 14, 2023
Generic NameATORVASTATIN CALCIUM
INGREDIENTS (11)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CALCIUM ACETATEInactive
Code: Y882YXF34X
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATEActive
Quantity: 80 mg in 1 1
Code: YRZ789OWMI
Classification: ACTIM