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
173474b6-26b4-46f2-a12a-64753ae5e905
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2023
Manufacturers
FDA
Lepu Pharmaceutical Technology Co., Ltd.
DUNS: 544490278
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 Code82137-017
Application NumberANDA216848
Product Classification
M
Marketing Category
C73584
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (12)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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 Code82137-016
Application NumberANDA216848
Product Classification
M
Marketing Category
C73584
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (12)
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ATORVASTATIN CALCIUM TRIHYDRATEActive
Quantity: 10 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM
atorvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82137-018
Application NumberANDA216848
Product Classification
M
Marketing Category
C73584
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (12)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
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 Code82137-019
Application NumberANDA216848
Product Classification
M
Marketing Category
C73584
G
Generic Name
atorvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (12)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
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
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ATORVASTATIN CALCIUM TRIHYDRATEActive
Quantity: 80 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM