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
5b839619-1805-c227-91bf-182f5b966ba4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2023
Manufacturers
FDA
Biocon Pharma Inc.
DUNS: 080000063
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 Code70377-078
Application NumberANDA216436
Product Classification
M
Marketing Category
C73584
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (12)
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ATORVASTATIN CALCIUM TRIHYDRATEActive
Quantity: 20 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM
atorvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70377-079
Application NumberANDA216436
Product Classification
M
Marketing Category
C73584
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (12)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ATORVASTATIN CALCIUM TRIHYDRATEActive
Quantity: 40 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM
atorvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70377-080
Application NumberANDA216436
Product Classification
M
Marketing Category
C73584
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (13)
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ATORVASTATIN CALCIUM TRIHYDRATEActive
Quantity: 80 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM
atorvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70377-077
Application NumberANDA216436
Product Classification
M
Marketing Category
C73584
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (12)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ATORVASTATIN CALCIUM TRIHYDRATEActive
Quantity: 10 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM