Lipitor
These highlights do not include all the information needed to use LIPITOR safely and effectively. See full prescribing information for LIPITOR. LIPITOR® (atorvastatin calcium) Tablets for oral administration Initial U.S. Approval: 1996
Approved
Approval ID
10a7ba02-42d6-4cae-8904-b256e2da5496
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 6, 2009
Manufacturers
FDA
Physicians Total Care, Inc
DUNS: 194123980
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 Code54868-3934
Application NumberNDA020702
Product Classification
M
Marketing Category
C73594
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2011
FDA Product Classification
INGREDIENTS (13)
ATORVASTATIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
atorvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4229
Application NumberNDA020702
Product Classification
M
Marketing Category
C73594
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2011
FDA Product Classification
INGREDIENTS (13)
ATORVASTATIN CALCIUMActive
Quantity: 40 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
atorvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3946
Application NumberNDA020702
Product Classification
M
Marketing Category
C73594
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2011
FDA Product Classification
INGREDIENTS (13)
ATORVASTATIN CALCIUMActive
Quantity: 20 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIB
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
atorvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4934
Application NumberNDA020702
Product Classification
M
Marketing Category
C73594
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2011
FDA Product Classification
INGREDIENTS (13)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
ATORVASTATIN CALCIUMActive
Quantity: 80 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT