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 administration Initial U.S. Approval: 1996

Approved

Approval ID

afd5c7b3-4886-4250-9a12-b61451f65eb5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 11, 2013

Manufacturers

FDA

Physicians Total Care, Inc.

DUNS: 194123980

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 Code54868-6319

Application NumberANDA076477

Product Classification

Marketing Category

C73584

Generic Name

Atorvastatin Calcium

Product Specifications

Route of AdministrationORAL

Effective DateJuly 11, 2013

FDA Product Classification

INGREDIENTS (18)

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

ATORVASTATIN CALCIUMActive

Quantity: 10 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

CANDELILLA WAXInactive

Code: WL0328HX19

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1A

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

METHYLCELLULOSE (400 CPS)Inactive

Code: O0GN6F9B2Y

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

POLYSORBATE 65Inactive

Code: 14BGY2Y3MJ

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

Atorvastatin Calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-6320

Application NumberANDA076477

Product Classification

Marketing Category

C73584

Generic Name

Atorvastatin Calcium

Product Specifications

Route of AdministrationORAL

Effective DateJuly 11, 2013

FDA Product Classification

INGREDIENTS (18)

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CANDELILLA WAXInactive

Code: WL0328HX19

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1A

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

ATORVASTATIN CALCIUMActive

Quantity: 20 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

POLYSORBATE 65Inactive

Code: 14BGY2Y3MJ

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 Code54868-6321

Application NumberANDA076477

Product Classification

Marketing Category

C73584

Generic Name

Atorvastatin Calcium

Product Specifications

Route of AdministrationORAL

Effective DateJuly 11, 2013

FDA Product Classification

INGREDIENTS (18)

ATORVASTATIN CALCIUMActive

Quantity: 40 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

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1A

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

POLYSORBATE 65Inactive

Code: 14BGY2Y3MJ

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

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 Code54868-6322

Application NumberANDA076477

Product Classification

Marketing Category

C73584

Generic Name

Atorvastatin Calcium

Product Specifications

Route of AdministrationORAL

Effective DateJuly 11, 2013

FDA Product Classification

INGREDIENTS (18)

CANDELILLA WAXInactive

Code: WL0328HX19

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 65Inactive

Code: 14BGY2Y3MJ

Classification: IACT

ATORVASTATIN CALCIUMActive

Quantity: 80 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1A

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

METHYLCELLULOSE (400 CPS)Inactive

Code: O0GN6F9B2Y

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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