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Carbidopa and Levodopa

Carbidopa and Levodopa Tablets, USP

Approved
Approval ID

843dc047-7273-4b63-b408-bf379da83022

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 17, 2019

Manufacturers
FDA

Aphena Pharma Solutions - Tennessee, LLC

DUNS: 128385585

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

carbidopa and levodopa

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43353-202
Application NumberANDA090324
Product Classification
M
Marketing Category
C73584
G
Generic Name
carbidopa and levodopa
Product Specifications
Route of AdministrationORAL
Effective DateJune 22, 2016
FDA Product Classification

INGREDIENTS (8)

CARBIDOPAActive
Quantity: 25 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIM
LEVODOPAActive
Quantity: 100 mg in 1 1
Code: 46627O600J
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT

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