Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aphena Pharma Solutions - Tennessee, LLC
Aphena Pharma Solutions - Tennessee, LLC
128385585
Products1
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
71610-269Application Number
ANDA073589Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 4, 2019MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 25 mg in 1 1
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 100 mg in 1 1
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT