MedPath
FDA Product

Carbidopa and levodopa

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Carbidopa and levodopa

70518-2909

Regulatory Information

70518-2909

ANDA074260

C73584

March 7, 2024

USA

Carbidopa and Levodopa Tablets, USP

HUMAN PRESCRIPTION DRUG LABEL

6

Company Information

REMEDYREPACK INC.

829572556

Active Ingredients

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

LEVODOPA

Quantity: 100 mg in 1 1

Code: 46627O600J

Class Code: ACTIB

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

CARBIDOPA

Quantity: 25 mg in 1 1

Code: MNX7R8C5VO

Class Code: ACTIM

Active Moieties

CARBIDOPA ANHYDROUS

Code: KR87B45RGH

LEVODOPA

Code: 46627O600J

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