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 administration Initial U.S. Approval: 1996

Approved

Approval ID

28e28cc3-349a-427a-b19c-77503ef43db4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 20, 2012

Manufacturers

FDA

Dispensing Solutions, Inc.

DUNS: 066070785

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 Code68258-6044

Application NumberANDA076477

Product Classification

Marketing Category

C73584

Generic Name

Atorvastatin Calcium

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 20, 2012

FDA Product Classification

INGREDIENTS (18)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

CANDELILLA WAXInactive

Code: WL0328HX19

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

METHYLCELLULOSE (400 CPS)Inactive

Code: O0GN6F9B2Y

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLYSORBATE 65Inactive

Code: 14BGY2Y3MJ

Classification: IACT

ATORVASTATIN CALCIUMActive

Quantity: 80 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

Atorvastatin Calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68258-6043

Application NumberANDA076477

Product Classification

Marketing Category

C73584

Generic Name

Atorvastatin Calcium

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 20, 2012

FDA Product Classification

INGREDIENTS (18)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

ATORVASTATIN CALCIUMActive

Quantity: 40 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CANDELILLA WAXInactive

Code: WL0328HX19

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

METHYLCELLULOSE (400 CPS)Inactive

Code: O0GN6F9B2Y

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

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

WATERInactive

Code: 059QF0KO0R

Classification: IACT

POLYSORBATE 65Inactive

Code: 14BGY2Y3MJ

Classification: IACT

Atorvastatin Calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68258-6042

Application NumberANDA076477

Product Classification

Marketing Category

C73584

Generic Name

Atorvastatin Calcium

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 20, 2012

FDA Product Classification

INGREDIENTS (18)

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

ATORVASTATIN CALCIUMActive

Quantity: 20 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

CANDELILLA WAXInactive

Code: WL0328HX19

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

POLYSORBATE 65Inactive

Code: 14BGY2Y3MJ

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

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

METHYLCELLULOSE (400 CPS)Inactive

Code: O0GN6F9B2Y

Classification: IACT

Atorvastatin Calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68258-6041

Application NumberANDA076477

Product Classification

Marketing Category

C73584

Generic Name

Atorvastatin Calcium

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 20, 2012

FDA Product Classification

INGREDIENTS (18)

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

ATORVASTATIN CALCIUMActive

Quantity: 10 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CANDELILLA WAXInactive

Code: WL0328HX19

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

POLYSORBATE 65Inactive

Code: 14BGY2Y3MJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

METHYLCELLULOSE (400 CPS)Inactive

Code: O0GN6F9B2Y

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

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Atorvastatin Calcium

Products 4

Atorvastatin Calcium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Atorvastatin Calcium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Atorvastatin Calcium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Atorvastatin Calcium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

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