Products6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Stalevo
Product Details
NDC Product Code
52427-827Application Number
NDA021485Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 31, 2019EntacaponeActive
Code: 4975G9NM6TClass: ACTIBQuantity: 200 mg in 1 1
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
povidone, unspecifiedInactive
Code: FZ989GH94EClass: IACT
sucroseInactive
Code: C151H8M554Class: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
glycerinInactive
Code: PDC6A3C0OXClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 31.25 mg in 1 1
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 125 mg in 1 1
starch, cornInactive
Code: O8232NY3SJClass: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
ferric oxide redInactive
Code: 1K09F3G675Class: IACT
Stalevo
Product Details
NDC Product Code
52427-816Application Number
NDA021485Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 31, 2019glycerinInactive
Code: PDC6A3C0OXClass: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
ferric oxide yellowInactive
Code: EX438O2MRTClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
povidone, unspecifiedInactive
Code: FZ989GH94EClass: IACT
ferric oxide redInactive
Code: 1K09F3G675Class: IACT
CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 25 mg in 1 1
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 100 mg in 1 1
EntacaponeActive
Code: 4975G9NM6TClass: ACTIBQuantity: 200 mg in 1 1
starch, cornInactive
Code: O8232NY3SJClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
sucroseInactive
Code: C151H8M554Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
Stalevo
Product Details
NDC Product Code
52427-805Application Number
NDA021485Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 31, 2019LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 50 mg in 1 1
EntacaponeActive
Code: 4975G9NM6TClass: ACTIBQuantity: 200 mg in 1 1
CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 12.5 mg in 1 1
starch, cornInactive
Code: O8232NY3SJClass: IACT
glycerinInactive
Code: PDC6A3C0OXClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
povidone, unspecifiedInactive
Code: FZ989GH94EClass: IACT
sucroseInactive
Code: C151H8M554Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
ferric oxide yellowInactive
Code: EX438O2MRTClass: IACT
ferric oxide redInactive
Code: 1K09F3G675Class: IACT
Stalevo
Product Details
NDC Product Code
52427-834Application Number
NDA021485Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 31, 2019CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 37.5 mg in 1 1
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 150 mg in 1 1
EntacaponeActive
Code: 4975G9NM6TClass: ACTIBQuantity: 200 mg in 1 1
starch, cornInactive
Code: O8232NY3SJClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
glycerinInactive
Code: PDC6A3C0OXClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
povidone, unspecifiedInactive
Code: FZ989GH94EClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
sucroseInactive
Code: C151H8M554Class: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
ferric oxide redInactive
Code: 1K09F3G675Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
ferric oxide yellowInactive
Code: EX438O2MRTClass: IACT
Stalevo
Product Details
NDC Product Code
52427-842Application Number
NDA021485Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 31, 2019starch, cornInactive
Code: O8232NY3SJClass: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
EntacaponeActive
Code: 4975G9NM6TClass: ACTIBQuantity: 200 mg in 1 1
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
glycerinInactive
Code: PDC6A3C0OXClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
povidone, unspecifiedInactive
Code: FZ989GH94EClass: IACT
sucroseInactive
Code: C151H8M554Class: IACT
ferric oxide redInactive
Code: 1K09F3G675Class: IACT
CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 50 mg in 1 1
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 200 mg in 1 1
Stalevo
Product Details
NDC Product Code
52427-809Application Number
NDA021485Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 31, 2019CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 18.75 mg in 1 1
glycerinInactive
Code: PDC6A3C0OXClass: IACT
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 75 mg in 1 1
EntacaponeActive
Code: 4975G9NM6TClass: ACTIBQuantity: 200 mg in 1 1
hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
povidone, unspecifiedInactive
Code: FZ989GH94EClass: IACT
starch, cornInactive
Code: O8232NY3SJClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
ferric oxide redInactive
Code: 1K09F3G675Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
sucroseInactive
Code: C151H8M554Class: IACT