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