Carbidopa, Levodopa and Entacapone

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CARBIDOPA, LEVODOPA AND ENTACAPONE TABLETS safely and effectively. See full prescribing information for CARBIDOPA, LEVODOPA AND ENTACAPONE TABLETS.CARBIDOPA, LEVODOPA AND ENTACAPONE TABLETS, for oral use Initial U.S. Approval: 2003

Approved

Approval ID

f0d9d7a8-1d06-4119-b2bc-42b3ec08d45b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 24, 2025

Manufacturers

FDA

Macleods Pharmaceuticals Limited

DUNS: 862128535

Products 6

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

Carbidopa, Levodopa and Entacapone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code33342-492

Application NumberANDA214495

Product Classification

Marketing Category

C73584

Generic Name

Carbidopa, Levodopa and Entacapone

Product Specifications

Route of AdministrationORAL

Effective DateApril 24, 2025

FDA Product Classification

INGREDIENTS (15)

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

CARBIDOPAActive

Quantity: 18.75 mg in 1 1

Code: MNX7R8C5VO

Classification: ACTIM

LEVODOPAActive

Quantity: 75 mg in 1 1

Code: 46627O600J

Classification: ACTIB

ENTACAPONEActive

Quantity: 200 mg in 1 1

Code: 4975G9NM6T

Classification: ACTIB

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CROSPOVIDONEInactive

Code: 68401960MK

Classification: IACT

Carbidopa, Levodopa and Entacapone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code33342-494

Application NumberANDA214495

Product Classification

Marketing Category

C73584

Generic Name

Carbidopa, Levodopa and Entacapone

Product Specifications

Route of AdministrationORAL

Effective DateApril 24, 2025

FDA Product Classification

INGREDIENTS (15)

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

CARBIDOPAActive

Quantity: 31.25 mg in 1 1

Code: MNX7R8C5VO

Classification: ACTIM

LEVODOPAActive

Quantity: 125 mg in 1 1

Code: 46627O600J

Classification: ACTIB

ENTACAPONEActive

Quantity: 200 mg in 1 1

Code: 4975G9NM6T

Classification: ACTIB

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CROSPOVIDONEInactive

Code: 68401960MK

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

Carbidopa, Levodopa and Entacapone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code33342-496

Application NumberANDA214495

Product Classification

Marketing Category

C73584

Generic Name

Carbidopa, Levodopa and Entacapone

Product Specifications

Route of AdministrationORAL

Effective DateApril 24, 2025

FDA Product Classification

INGREDIENTS (15)

CARBIDOPAActive

Quantity: 50 mg in 1 1

Code: MNX7R8C5VO

Classification: ACTIM

LEVODOPAActive

Quantity: 200 mg in 1 1

Code: 46627O600J

Classification: ACTIB

ENTACAPONEActive

Quantity: 200 mg in 1 1

Code: 4975G9NM6T

Classification: ACTIB

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CROSPOVIDONEInactive

Code: 68401960MK

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

Carbidopa, Levodopa and Entacapone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code33342-495

Application NumberANDA214495

Product Classification

Marketing Category

C73584

Generic Name

Carbidopa, Levodopa and Entacapone

Product Specifications

Route of AdministrationORAL

Effective DateApril 24, 2025

FDA Product Classification

INGREDIENTS (15)

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

CARBIDOPAActive

Quantity: 37.5 mg in 1 1

Code: MNX7R8C5VO

Classification: ACTIM

LEVODOPAActive

Quantity: 150 mg in 1 1

Code: 46627O600J

Classification: ACTIB

ENTACAPONEActive

Quantity: 200 mg in 1 1

Code: 4975G9NM6T

Classification: ACTIB

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CROSPOVIDONEInactive

Code: 68401960MK

Classification: IACT

Carbidopa, Levodopa and Entacapone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code33342-493

Application NumberANDA214495

Product Classification

Marketing Category

C73584

Generic Name

Carbidopa, Levodopa and Entacapone

Product Specifications

Route of AdministrationORAL

Effective DateApril 24, 2025

FDA Product Classification

INGREDIENTS (15)

CARBIDOPAActive

Quantity: 25 mg in 1 1

Code: MNX7R8C5VO

Classification: ACTIM

LEVODOPAActive

Quantity: 100 mg in 1 1

Code: 46627O600J

Classification: ACTIB

ENTACAPONEActive

Quantity: 200 mg in 1 1

Code: 4975G9NM6T

Classification: ACTIB

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CROSPOVIDONEInactive

Code: 68401960MK

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

Carbidopa, Levodopa and Entacapone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code33342-491

Application NumberANDA214495

Product Classification

Marketing Category

C73584

Generic Name

Carbidopa, Levodopa and Entacapone

Product Specifications

Route of AdministrationORAL

Effective DateApril 24, 2025

FDA Product Classification

INGREDIENTS (15)

CARBIDOPAActive

Quantity: 12.5 mg in 1 1

Code: MNX7R8C5VO

Classification: ACTIM

LEVODOPAActive

Quantity: 50 mg in 1 1

Code: 46627O600J

Classification: ACTIB

ENTACAPONEActive

Quantity: 200 mg in 1 1

Code: 4975G9NM6T

Classification: ACTIB

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CROSPOVIDONEInactive

Code: 68401960MK

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

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Carbidopa, Levodopa and Entacapone

Products 6

Carbidopa, Levodopa and Entacapone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Carbidopa, Levodopa and Entacapone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Carbidopa, Levodopa and Entacapone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Carbidopa, Levodopa and Entacapone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Carbidopa, Levodopa and Entacapone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Carbidopa, Levodopa and Entacapone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

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