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
f00a83aa-3f1d-566d-b9bb-f396f22a27cb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2023
Manufacturers
FDA
Quallent
DUNS: 815564528
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ATORVASTATIN CALCIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82009-003
Application NumberANDA090548
Product Classification
M
Marketing Category
C73584
G
Generic Name
ATORVASTATIN CALCIUM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (11)
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATEActive
Quantity: 40 mg in 1 1
Code: YRZ789OWMI
Classification: ACTIM
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
CALCIUM ACETATEInactive
Code: Y882YXF34X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ATORVASTATIN CALCIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82009-001
Application NumberANDA090548
Product Classification
M
Marketing Category
C73584
G
Generic Name
ATORVASTATIN CALCIUM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (11)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CALCIUM ACETATEInactive
Code: Y882YXF34X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATEActive
Quantity: 10 mg in 1 1
Code: YRZ789OWMI
Classification: ACTIM
ATORVASTATIN CALCIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82009-002
Application NumberANDA090548
Product Classification
M
Marketing Category
C73584
G
Generic Name
ATORVASTATIN CALCIUM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (11)
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CALCIUM ACETATEInactive
Code: Y882YXF34X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
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: 20 mg in 1 1
Code: YRZ789OWMI
Classification: ACTIM
ATORVASTATIN CALCIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82009-004
Application NumberANDA090548
Product Classification
M
Marketing Category
C73584
G
Generic Name
ATORVASTATIN CALCIUM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (11)
CALCIUM ACETATEInactive
Code: Y882YXF34X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATEActive
Quantity: 80 mg in 1 1
Code: YRZ789OWMI
Classification: ACTIM