Carbidopa and Levodopa
CARBIDOPA AND LEVODOPA TABLETS USP029202930294Rx only
Approved
Approval ID
a7b37778-d198-4799-8bf0-92576cff02b9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 2, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-1334
Application NumberANDA073589
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbidopa and Levodopa
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2012
FDA Product Classification
INGREDIENTS (7)
LEVODOPAActive
Quantity: 100 mg in 1 1
Code: 46627O600J
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARBIDOPAActive
Quantity: 25 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Carbidopa and Levodopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-2866
Application NumberANDA073618
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbidopa and Levodopa
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2012
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CARBIDOPAActive
Quantity: 10 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIB
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 Code54868-2834
Application NumberANDA073607
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbidopa and Levodopa
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2012
FDA Product Classification
INGREDIENTS (6)
CARBIDOPAActive
Quantity: 25 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIB
LEVODOPAActive
Quantity: 250 mg in 1 1
Code: 46627O600J
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT