Stalevo

These highlights do not include all the information needed to use STALEVO safely and effectively. See full prescribing information for STALEVO. STALEVO (carbidopa, levodopa and entacapone) tablets, for oral useInitial U.S. Approval: 2003

Approved

Approval ID

53c488d8-4146-7563-8021-d90c931d1a95

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 30, 2021

Manufacturers

FDA

Almatica Pharma LLC

DUNS: 962454505

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 Code52427-827

Application NumberNDA021485

Product Classification

Marketing Category

C73594

Generic Name

carbidopa, levodopa, and entacapone

Product Specifications

Route of AdministrationORAL

Effective DateDecember 31, 2019

FDA Product Classification

INGREDIENTS (14)

entacaponeActive

Quantity: 200 mg in 1 1

Code: 4975G9NM6T

Classification: ACTIB

croscarmellose sodiumInactive

Code: M28OL1HH48

Classification: IACT

povidone, unspecifiedInactive

Code: FZ989GH94E

Classification: IACT

sucroseInactive

Code: C151H8M554

Classification: IACT

hypromellose, unspecifiedInactive

Code: 3NXW29V3WO

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

glycerinInactive

Code: PDC6A3C0OX

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

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

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

mannitolInactive

Code: 3OWL53L36A

Classification: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8H

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 Code52427-816

Application NumberNDA021485

Product Classification

Marketing Category

C73594

Generic Name

carbidopa, levodopa, and entacapone

Product Specifications

Route of AdministrationORAL

Effective DateDecember 31, 2019

FDA Product Classification

INGREDIENTS (15)

glycerinInactive

Code: PDC6A3C0OX

Classification: IACT

hypromellose, unspecifiedInactive

Code: 3NXW29V3WO

Classification: IACT

mannitolInactive

Code: 3OWL53L36A

Classification: IACT

ferric oxide yellowInactive

Code: EX438O2MRT

Classification: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

povidone, unspecifiedInactive

Code: FZ989GH94E

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

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

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

croscarmellose sodiumInactive

Code: M28OL1HH48

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

sucroseInactive

Code: C151H8M554

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

carbidopa, levodopa, and entacapone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code52427-805

Application NumberNDA021485

Product Classification

Marketing Category

C73594

Generic Name

carbidopa, levodopa, and entacapone

Product Specifications

Route of AdministrationORAL

Effective DateDecember 31, 2019

FDA Product Classification

INGREDIENTS (15)

levodopaActive

Quantity: 50 mg in 1 1

Code: 46627O600J

Classification: ACTIB

entacaponeActive

Quantity: 200 mg in 1 1

Code: 4975G9NM6T

Classification: ACTIB

carbidopaActive

Quantity: 12.5 mg in 1 1

Code: MNX7R8C5VO

Classification: ACTIM

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

glycerinInactive

Code: PDC6A3C0OX

Classification: IACT

croscarmellose sodiumInactive

Code: M28OL1HH48

Classification: IACT

hypromellose, unspecifiedInactive

Code: 3NXW29V3WO

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

mannitolInactive

Code: 3OWL53L36A

Classification: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

povidone, unspecifiedInactive

Code: FZ989GH94E

Classification: IACT

sucroseInactive

Code: C151H8M554

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

ferric oxide yellowInactive

Code: EX438O2MRT

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 Code52427-834

Application NumberNDA021485

Product Classification

Marketing Category

C73594

Generic Name

carbidopa, levodopa, and entacapone

Product Specifications

Route of AdministrationORAL

Effective DateDecember 31, 2019

FDA Product Classification

INGREDIENTS (15)

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

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

croscarmellose sodiumInactive

Code: M28OL1HH48

Classification: IACT

glycerinInactive

Code: PDC6A3C0OX

Classification: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

povidone, unspecifiedInactive

Code: FZ989GH94E

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

mannitolInactive

Code: 3OWL53L36A

Classification: IACT

sucroseInactive

Code: C151H8M554

Classification: IACT

hypromellose, unspecifiedInactive

Code: 3NXW29V3WO

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

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 Code52427-842

Application NumberNDA021485

Product Classification

Marketing Category

C73594

Generic Name

carbidopa, levodopa, and entacapone

Product Specifications

Route of AdministrationORAL

Effective DateDecember 31, 2019

FDA Product Classification

INGREDIENTS (14)

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

hypromellose, unspecifiedInactive

Code: 3NXW29V3WO

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

mannitolInactive

Code: 3OWL53L36A

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

entacaponeActive

Quantity: 200 mg in 1 1

Code: 4975G9NM6T

Classification: ACTIB

croscarmellose sodiumInactive

Code: M28OL1HH48

Classification: IACT

glycerinInactive

Code: PDC6A3C0OX

Classification: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

povidone, unspecifiedInactive

Code: FZ989GH94E

Classification: IACT

sucroseInactive

Code: C151H8M554

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

carbidopaActive

Quantity: 50 mg in 1 1

Code: MNX7R8C5VO

Classification: ACTIM

levodopaActive

Quantity: 200 mg in 1 1

Code: 46627O600J

Classification: ACTIB

carbidopa, levodopa, and entacapone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code52427-809

Application NumberNDA021485

Product Classification

Marketing Category

C73594

Generic Name

carbidopa, levodopa, and entacapone

Product Specifications

Route of AdministrationORAL

Effective DateDecember 31, 2019

FDA Product Classification

INGREDIENTS (14)

carbidopaActive

Quantity: 18.75 mg in 1 1

Code: MNX7R8C5VO

Classification: ACTIM

glycerinInactive

Code: PDC6A3C0OX

Classification: IACT

levodopaActive

Quantity: 75 mg in 1 1

Code: 46627O600J

Classification: ACTIB

entacaponeActive

Quantity: 200 mg in 1 1

Code: 4975G9NM6T

Classification: ACTIB

hypromellose, unspecifiedInactive

Code: 3NXW29V3WO

Classification: IACT

mannitolInactive

Code: 3OWL53L36A

Classification: IACT

povidone, unspecifiedInactive

Code: FZ989GH94E

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

croscarmellose sodiumInactive

Code: M28OL1HH48

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

sucroseInactive

Code: C151H8M554

Classification: IACT

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Stalevo

Products 6

carbidopa, levodopa, and entacapone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

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 (14)

carbidopa, levodopa, and entacapone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

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Company

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