Carbidopa, levodopa and entacapone

Basic Information

Product Name

FDA Product Code

47335-005

Regulatory Information

NDC Product Code

47335-005

Application Number

NDA021485

Marketing Category

C73605

Effective Date

March 1, 2019

Territorial Authority

USA

FDA Title

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

Labeling Type

Human Prescription Drug Label

Version Number

Active Ingredients

LEVODOPA

Quantity: 150 mg in 1 1

Code: 46627O600J

Class Code: ACTIB

CARBIDOPA

Quantity: 37.5 mg in 1 1

Code: MNX7R8C5VO

Class Code: ACTIM

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

ENTACAPONE

Quantity: 200 mg in 1 1

Code: 4975G9NM6T

Class Code: ACTIB

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

Active Moieties

CARBIDOPA ANHYDROUS

Code: KR87B45RGH

LEVODOPA

Code: 46627O600J

ENTACAPONE

Code: 4975G9NM6T

Basic Information

Regulatory Information

Company Information

Active Ingredients

GLYCERIN

CROSCARMELLOSE SODIUM

HYPROMELLOSES

MANNITOL

TITANIUM DIOXIDE

MAGNESIUM STEARATE

FERRIC OXIDE YELLOW

STARCH, CORN

POLYSORBATE 80

POVIDONE

SUCROSE

FERRIC OXIDE RED

Active Moieties

CARBIDOPA ANHYDROUS

LEVODOPA

ENTACAPONE