Carbidopa and Levodopa
Carbidopa and Levodopa Tablets, USP Ronly
Approved
Approval ID
4ced8a05-27ac-463f-b331-387e473fdaa1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2022
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 3
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 Code59651-456
Application NumberANDA216537
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbidopa and Levodopa
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2022
FDA Product Classification
INGREDIENTS (8)
CARBIDOPAActive
Quantity: 10 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIM
CROSPOVIDONE (35 .MU.M)Inactive
Code: 40UAA97IT9
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
LEVODOPAActive
Quantity: 100 mg in 1 1
Code: 46627O600J
Classification: ACTIB
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Carbidopa and Levodopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-457
Application NumberANDA216537
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbidopa and Levodopa
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2022
FDA Product Classification
INGREDIENTS (8)
CARBIDOPAActive
Quantity: 25 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIM
CROSPOVIDONE (35 .MU.M)Inactive
Code: 40UAA97IT9
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LEVODOPAActive
Quantity: 100 mg in 1 1
Code: 46627O600J
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Carbidopa and Levodopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-458
Application NumberANDA216537
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbidopa and Levodopa
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2022
FDA Product Classification
INGREDIENTS (8)
LEVODOPAActive
Quantity: 250 mg in 1 1
Code: 46627O600J
Classification: ACTIB
CARBIDOPAActive
Quantity: 25 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
CROSPOVIDONE (35 .MU.M)Inactive
Code: 40UAA97IT9
Classification: IACT