Carbidopa-levodopa
Carbidopa and Levodopa Tablets, USP
Approved
Approval ID
d1bb319b-82a3-4b66-9cdc-f77fdb8383ce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 8, 2023
Manufacturers
FDA
TruPharma, LLC
DUNS: 078533947
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 Code52817-392
Application NumberANDA216505
Product Classification
M
Marketing Category
C73584
G
Generic Name
carbidopa and levodopa
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2023
FDA Product Classification
INGREDIENTS (7)
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CARBIDOPAActive
Quantity: 25 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIM
LEVODOPAActive
Quantity: 250 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
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
carbidopa and levodopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52817-390
Application NumberANDA216505
Product Classification
M
Marketing Category
C73584
G
Generic Name
carbidopa and levodopa
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2023
FDA Product Classification
INGREDIENTS (7)
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
LEVODOPAActive
Quantity: 100 mg in 1 1
Code: 46627O600J
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARBIDOPAActive
Quantity: 10 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIM
carbidopa and levodopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52817-391
Application NumberANDA216505
Product Classification
M
Marketing Category
C73584
G
Generic Name
carbidopa and levodopa
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2023
FDA Product Classification
INGREDIENTS (7)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
LEVODOPAActive
Quantity: 100 mg in 1 1
Code: 46627O600J
Classification: ACTIB
CARBIDOPAActive
Quantity: 25 mg in 1 1
Code: MNX7R8C5VO
Classification: ACTIM