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FDA Product

Carbidopa and Levodopa

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

Basic Information

Carbidopa and Levodopa

68084-282

Regulatory Information

68084-282

ANDA077828

C73584

October 4, 2022

USA

Carbidopa and Levodopa Extended-release Tablets 8228101/0715 Rx only

HUMAN PRESCRIPTION DRUG LABEL

8

Company Information

929561009

Active Ingredients

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

LEVODOPA

Quantity: 200 mg in 1 1

Code: 46627O600J

Class Code: ACTIB

CARBIDOPA

Quantity: 50 mg in 1 1

Code: MNX7R8C5VO

Class Code: ACTIM

HYPROMELLOSE 2208 (100 MPA.S)

Code: B1QE5P712K

Class Code: IACT

Active Moieties

CARBIDOPA ANHYDROUS

Code: KR87B45RGH

LEVODOPA

Code: 46627O600J

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