ATORVASTATIN CALCIUM

These highlights do not include all the information needed to use atorvastatin calcium safely and effectively. See full prescribing information for atorvastatin calcium tablets. ATORVASTATIN calcium tablets for oral use Initial U.S. Approval: 19 9 6

Approved

Approval ID

64abfa40-e0ab-46ae-8c7c-7c199b89b7c1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 17, 2018

Manufacturers

FDA

Marlex Pharmaceuticals Inc

DUNS: 782540215

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 Code10135-653

Application NumberANDA205519

Product Classification

Marketing Category

C73584

Generic Name

ATORVASTATIN CALCIUM

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 12, 2018

FDA Product Classification

INGREDIENTS (15)

ATORVASTATIN CALCIUMActive

Quantity: 80 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

COPOVIDONEInactive

Code: D9C330MD8B

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SODIUM CARBONATEInactive

Code: 45P3261C7T

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

XANTHAN GUMInactive

Code: TTV12P4NEE

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

ATORVASTATIN CALCIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code10135-651

Application NumberANDA205519

Product Classification

Marketing Category

C73584

Generic Name

ATORVASTATIN CALCIUM

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 12, 2018

FDA Product Classification

INGREDIENTS (16)

ATORVASTATIN CALCIUMActive

Quantity: 40 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

COPOVIDONEInactive

Code: D9C330MD8B

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

SODIUM CARBONATEInactive

Code: 45P3261C7T

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

EGG PHOSPHOLIPIDSInactive

Code: 1Z74184RGV

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

XANTHAN GUMInactive

Code: TTV12P4NEE

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

ATORVASTATIN CALCIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code10135-650

Application NumberANDA205519

Product Classification

Marketing Category

C73584

Generic Name

ATORVASTATIN CALCIUM

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 12, 2018

FDA Product Classification

INGREDIENTS (16)

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

ATORVASTATIN CALCIUMActive

Quantity: 20 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SODIUM CARBONATEInactive

Code: 45P3261C7T

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

EGG PHOSPHOLIPIDSInactive

Code: 1Z74184RGV

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

XANTHAN GUMInactive

Code: TTV12P4NEE

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

COPOVIDONEInactive

Code: D9C330MD8B

Classification: IACT

ATORVASTATIN CALCIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code10135-649

Application NumberANDA205519

Product Classification

Marketing Category

C73584

Generic Name

ATORVASTATIN CALCIUM

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 12, 2018

FDA Product Classification

INGREDIENTS (16)

ATORVASTATIN CALCIUMActive

Quantity: 10 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

COPOVIDONEInactive

Code: D9C330MD8B

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SODIUM CARBONATEInactive

Code: 45P3261C7T

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

EGG PHOSPHOLIPIDSInactive

Code: 1Z74184RGV

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

XANTHAN GUMInactive

Code: TTV12P4NEE

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

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ATORVASTATIN CALCIUM

Products 4

ATORVASTATIN CALCIUM

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

ATORVASTATIN CALCIUM

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

ATORVASTATIN CALCIUM

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

ATORVASTATIN CALCIUM

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

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