Carbidopa and levodopa
Carbidopa and Levodopa Tablets, USP
Approved
Approval ID
61a00944-8129-4068-a9d8-69949f9248d4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 5, 2021
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 Code71610-579
Application NumberANDA074260
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbidopa and levodopa
Product Specifications
Route of AdministrationORAL
Effective DateAugust 5, 2021
FDA Product Classification
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARBIDOPAActive
Quantity: 25 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LEVODOPAActive
Quantity: 100 mg in 1 1
Code: 46627O600J
Classification: ACTIB