Carbidopa and Levodopa
Carbidopa and Levodopa Extended-Release Tablets, USP Rx only
Approved
Approval ID
33a22ffe-0d41-162d-e063-6394a90a43d3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 25, 2025
Manufacturers
FDA
Radha Pharmaceuticals Inc
DUNS: 117634222
Products 2
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 Code77771-460
Application NumberANDA214091
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbidopa and Levodopa
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2025
FDA Product Classification
INGREDIENTS (6)
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CARBIDOPAActive
Quantity: 25 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIM
LEVODOPAActive
Quantity: 100 mg in 1 1
Code: 46627O600J
Classification: ACTIB
Carbidopa and Levodopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code77771-461
Application NumberANDA214091
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbidopa and Levodopa
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2025
FDA Product Classification
INGREDIENTS (6)
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CARBIDOPAActive
Quantity: 50 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIM
LEVODOPAActive
Quantity: 200 mg in 1 1
Code: 46627O600J
Classification: ACTIB