Carbidopa-levodopa

Basic Information

Product Name

Carbidopa-levodopa

FDA Product Code

52817-392

Regulatory Information

NDC Product Code

52817-392

Application Number

ANDA216505

Marketing Category

C73584

Effective Date

April 8, 2023

Territorial Authority

USA

FDA Title

Carbidopa and Levodopa Tablets, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 9XZ8H6N6OH

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

CARBIDOPA

Quantity: 25 mg in 1 1

Code: MNX7R8C5VO

Class Code: ACTIM

LEVODOPA

Quantity: 250 mg in 1 1

Code: 46627O600J

Class Code: ACTIB

FD&C BLUE NO. 2--ALUMINUM LAKE

Code: 4AQJ3LG584

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

CARBIDOPA ANHYDROUS

Code: KR87B45RGH

LEVODOPA

Code: 46627O600J

Basic Information

Regulatory Information

Company Information

Active Ingredients

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

CROSPOVIDONE

FD&C BLUE NO. 2--ALUMINUM LAKE

MICROCRYSTALLINE CELLULOSE

MAGNESIUM STEARATE

Active Moieties

CARBIDOPA ANHYDROUS

LEVODOPA