Carbidopa and Levodopa
Approved
Approval ID
abff005f-23fc-4d1e-b469-88aa07589a43
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5659
Application NumberANDA077828
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbidopa and Levodopa
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2010
FDA Product Classification
INGREDIENTS (9)
CARBIDOPAActive
Quantity: 25 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIM
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LEVODOPAActive
Quantity: 100 mg in 1 1
Code: 46627O600J
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Carbidopa and Levodopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5776
Application NumberANDA077828
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbidopa and Levodopa
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2010
FDA Product Classification
INGREDIENTS (9)
LEVODOPAActive
Quantity: 200 mg in 1 1
Code: 46627O600J
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARBIDOPAActive
Quantity: 50 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIM
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT