Carbidopa and Levodopa
CARBIDOPA AND LEVODOPA TABLETS, USP
Approved
Approval ID
3f6d393e-ac84-4a3c-a837-199d1ec71fd2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2025
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
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 Code0904-7549
Application NumberANDA073607
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbidopa and Levodopa
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2025
FDA Product Classification
INGREDIENTS (6)
CARBIDOPAActive
Quantity: 25 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIM
LEVODOPAActive
Quantity: 250 mg in 1 1
Code: 46627O600J
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Carbidopa and Levodopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-7501
Application NumberANDA073589
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbidopa and Levodopa
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2025
FDA Product Classification
INGREDIENTS (7)
CARBIDOPAActive
Quantity: 25 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIM
LEVODOPAActive
Quantity: 100 mg in 1 1
Code: 46627O600J
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEInactive
Code: GYP6Z2JR6Q
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT