Ditropan
DITROPAN XL (oxybutynin chloride)Extended Release Tablets
Approved
Approval ID
2b0384a5-c65a-454d-9761-716af8afe5bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oxybutynin chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4835
Application NumberNDA020897
Product Classification
M
Marketing Category
C73594
G
Generic Name
oxybutynin chloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2012
FDA Product Classification
INGREDIENTS (10)
oxybutynin chlorideActive
Quantity: 15 mg in 1 1
Code: L9F3D9RENQ
Classification: ACTIB
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
cellulose acetateInactive
Code: 3J2P07GVB6
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
butylated hydroxytolueneInactive
Code: 1P9D0Z171K
Classification: IACT
oxybutynin chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4610
Application NumberNDA020897
Product Classification
M
Marketing Category
C73594
G
Generic Name
oxybutynin chloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2012
FDA Product Classification
INGREDIENTS (10)
oxybutynin chlorideActive
Quantity: 5 mg in 1 1
Code: L9F3D9RENQ
Classification: ACTIB
cellulose acetateInactive
Code: 3J2P07GVB6
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
butylated hydroxytolueneInactive
Code: 1P9D0Z171K
Classification: IACT
oxybutynin chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4502
Application NumberNDA020897
Product Classification
M
Marketing Category
C73594
G
Generic Name
oxybutynin chloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2012
FDA Product Classification
INGREDIENTS (10)
butylated hydroxytolueneInactive
Code: 1P9D0Z171K
Classification: IACT
oxybutynin chlorideActive
Quantity: 10 mg in 1 1
Code: L9F3D9RENQ
Classification: ACTIB
cellulose acetateInactive
Code: 3J2P07GVB6
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT