Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ditropan XL
Product Details
NDC Product Code
54868-4835Application Number
NDA020897Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
February 16, 2012OxybutyninActive
Code: L9F3D9RENQClass: ACTIBQuantity: 15 mg in 1 1
lactoseInactive
Code: J2B2A4N98GClass: IACT
cellulose acetateInactive
Code: 3J2P07GVB6Class: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1AClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
butylated hydroxytolueneInactive
Code: 1P9D0Z171KClass: IACT
Ditropan XL
Product Details
NDC Product Code
54868-4610Application Number
NDA020897Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
February 16, 2012OxybutyninActive
Code: L9F3D9RENQClass: ACTIBQuantity: 5 mg in 1 1
cellulose acetateInactive
Code: 3J2P07GVB6Class: IACT
lactoseInactive
Code: J2B2A4N98GClass: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1AClass: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
butylated hydroxytolueneInactive
Code: 1P9D0Z171KClass: IACT
Ditropan XL
Product Details
NDC Product Code
54868-4502Application Number
NDA020897Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
February 16, 2012butylated hydroxytolueneInactive
Code: 1P9D0Z171KClass: IACT
OxybutyninActive
Code: L9F3D9RENQClass: ACTIBQuantity: 10 mg in 1 1
cellulose acetateInactive
Code: 3J2P07GVB6Class: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
lactoseInactive
Code: J2B2A4N98GClass: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1AClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT