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
f60a672d-8d6d-4d67-9a47-5547357e7b5b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 2, 2010
Manufacturers
FDA
PHARMAKON, LLC
DUNS: 964749860
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 Code49299-1090
Application NumberNDA020702
Product Classification
M
Marketing Category
C73594
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 3, 2010
FDA Product Classification
INGREDIENTS (13)
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
atorvastatin calciumActive
Quantity: 10 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIB
calcium carbonateInactive
Code: H0G9379FGK
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
candelilla waxInactive
Code: WL0328HX19
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
atorvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49299-1092
Application NumberNDA020702
Product Classification
M
Marketing Category
C73594
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 3, 2010
FDA Product Classification
INGREDIENTS (13)
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
atorvastatin calciumActive
Quantity: 40 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
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
atorvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49299-1091
Application NumberNDA020702
Product Classification
M
Marketing Category
C73594
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 3, 2010
FDA Product Classification
INGREDIENTS (13)
candelilla waxInactive
Code: WL0328HX19
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
atorvastatin calciumActive
Quantity: 20 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIB
calcium carbonateInactive
Code: H0G9379FGK
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
atorvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49299-1093
Application NumberNDA020702
Product Classification
M
Marketing Category
C73594
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 3, 2010
FDA Product Classification
INGREDIENTS (13)
atorvastatin calciumActive
Quantity: 80 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
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT