Atorvastatin Calcium
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1996
Approved
Approval ID
d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 14, 2023
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
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 Code0378-3951
Application NumberANDA091226
Product Classification
M
Marketing Category
C73584
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2020
FDA Product Classification
INGREDIENTS (15)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: CNTM
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: CNTM
ARGININEInactive
Code: 94ZLA3W45F
Classification: IACT
ATORVASTATIN CALCIUM TRIHYDRATEActive
Quantity: 20 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: CNTM
atorvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-3953
Application NumberANDA091226
Product Classification
M
Marketing Category
C73584
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2020
FDA Product Classification
INGREDIENTS (15)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ARGININEInactive
Code: 94ZLA3W45F
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: CNTM
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: CNTM
ATORVASTATIN CALCIUM TRIHYDRATEActive
Quantity: 80 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: CNTM
atorvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-3952
Application NumberANDA091226
Product Classification
M
Marketing Category
C73584
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2020
FDA Product Classification
INGREDIENTS (15)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: CNTM
ARGININEInactive
Code: 94ZLA3W45F
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: CNTM
ATORVASTATIN CALCIUM TRIHYDRATEActive
Quantity: 40 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: CNTM
atorvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-3950
Application NumberANDA091226
Product Classification
M
Marketing Category
C73584
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2020
FDA Product Classification
INGREDIENTS (15)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ARGININEInactive
Code: 94ZLA3W45F
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: CNTM
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: CNTM
ATORVASTATIN CALCIUM TRIHYDRATEActive
Quantity: 10 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: CNTM