Products2
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 Code
0378-0094Application Number
ANDA075091Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 25, 2022CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 50 mg in 1 1
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57TClass: IACT
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 200 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Carbidopa and Levodopa
Product Details
NDC Product Code
0378-0088Application Number
ANDA075091Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 25, 2022CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 25 mg in 1 1
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 100 mg in 1 1
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57TClass: IACT