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
71610-579Application Number
ANDA074260Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 5, 2021STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 25 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 100 mg in 1 1