Carbidopa and Levodopa
Approved
Approval ID
16f9e4d1-6953-4d4f-b4cf-ad95a856ac25
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2024
Manufacturers
FDA
Mylan Institutional Inc.
DUNS: 039615992
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
NDC Product Code51079-923
Application NumberANDA075091
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 3, 2024
Generic Namecarbidopa and levodopa
INGREDIENTS (7)
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
CARBIDOPAActive
Quantity: 50 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIM
LEVODOPAActive
Quantity: 200 mg in 1 1
Code: 46627O600J
Classification: ACTIB
carbidopa and levodopa
PRODUCT DETAILS
NDC Product Code51079-978
Application NumberANDA075091
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 3, 2024
Generic Namecarbidopa and levodopa
INGREDIENTS (7)
CARBIDOPAActive
Quantity: 25 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIM
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LEVODOPAActive
Quantity: 100 mg in 1 1
Code: 46627O600J
Classification: ACTIB