SIMVASTATIN

These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral useInitial U.S. Approval: 1991

Approved

Approval ID

3e48217f-8175-4e9b-9fd0-909be4bbba95

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 19, 2024

Manufacturers

FDA

Lupin Pharmaceuticals, Inc.

DUNS: 089153071

Products 7

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

SIMVASTATIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68180-479

Application NumberANDA078103

Product Classification

Marketing Category

C73584

Generic Name

SIMVASTATIN

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 19, 2024

FDA Product Classification

INGREDIENTS (13)

SIMVASTATINActive

Quantity: 20 mg in 1 1

Code: AGG2FN16EV

Classification: ACTIB

ASCORBIC ACIDInactive

Code: PQ6CK8PD0R

Classification: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2U

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SIMVASTATIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68180-464

Application NumberANDA078103

Product Classification

Marketing Category

C73584

Generic Name

SIMVASTATIN

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 19, 2024

FDA Product Classification

INGREDIENTS (13)

SIMVASTATINActive

Quantity: 40 mg in 1 1

Code: AGG2FN16EV

Classification: ACTIB

ASCORBIC ACIDInactive

Code: PQ6CK8PD0R

Classification: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2U

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SIMVASTATIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68180-478

Application NumberANDA078103

Product Classification

Marketing Category

C73584

Generic Name

SIMVASTATIN

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 19, 2024

FDA Product Classification

INGREDIENTS (13)

SIMVASTATINActive

Quantity: 10 mg in 1 1

Code: AGG2FN16EV

Classification: ACTIB

ASCORBIC ACIDInactive

Code: PQ6CK8PD0R

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2U

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SIMVASTATIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68180-465

Application NumberANDA078103

Product Classification

Marketing Category

C73584

Generic Name

SIMVASTATIN

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 19, 2024

FDA Product Classification

INGREDIENTS (13)

SIMVASTATINActive

Quantity: 80 mg in 1 1

Code: AGG2FN16EV

Classification: ACTIB

ASCORBIC ACIDInactive

Code: PQ6CK8PD0R

Classification: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2U

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SIMVASTATIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68180-480

Application NumberANDA078103

Product Classification

Marketing Category

C73584

Generic Name

SIMVASTATIN

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 19, 2024

FDA Product Classification

INGREDIENTS (13)

ASCORBIC ACIDInactive

Code: PQ6CK8PD0R

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

SIMVASTATINActive

Quantity: 40 mg in 1 1

Code: AGG2FN16EV

Classification: ACTIB

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2U

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

SIMVASTATIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68180-482

Application NumberANDA078103

Product Classification

Marketing Category

C73584

Generic Name

SIMVASTATIN

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 19, 2024

FDA Product Classification

INGREDIENTS (13)

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SIMVASTATINActive

Quantity: 5 mg in 1 1

Code: AGG2FN16EV

Classification: ACTIB

ASCORBIC ACIDInactive

Code: PQ6CK8PD0R

Classification: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2U

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SIMVASTATIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68180-481

Application NumberANDA078103

Product Classification

Marketing Category

C73584

Generic Name

SIMVASTATIN

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 19, 2024

FDA Product Classification

INGREDIENTS (13)

SIMVASTATINActive

Quantity: 80 mg in 1 1

Code: AGG2FN16EV

Classification: ACTIB

ASCORBIC ACIDInactive

Code: PQ6CK8PD0R

Classification: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2U

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

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SIMVASTATIN

Products 7

SIMVASTATIN

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

SIMVASTATIN

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

SIMVASTATIN

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

SIMVASTATIN

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

SIMVASTATIN

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

SIMVASTATIN

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

SIMVASTATIN

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

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