15 mg

Rx only

Ditropan XL®and OROS®are registered
trademarks of ALZA Corporation.

DITROPAN  XL
oxybutynin chloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-805
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
oxybutynin chloride (oxybutynin)  oxybutynin chloride 5 mg
 
Inactive Ingredients
Ingredient Name Strength
cellulose acetate  
hypromelloses  
lactose  
magnesium stearate  
polyethylene glycols  
titanium dioxide  
polysorbate 80  
sodium chloride  
butylated hydroxytoluene  
 
Product Characteristics
Color YELLOW (pale yellow)  Score no score 
Shape ROUND Size 8mm
Flavor  Imprint Code 5;XL 
Contains     
 
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50458-805-01 100 TABLET, EXTENDED RELEASE ( TABLET) in 1 BOTTLE None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020897 06/26/1999 

DITROPAN  XL
oxybutynin chloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-810
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
oxybutynin chloride (oxybutynin)  oxybutynin chloride 10 mg
 
Inactive Ingredients
Ingredient Name Strength
cellulose acetate  
hypromelloses  
lactose  
magnesium stearate  
polyethylene glycols  
titanium dioxide  
polysorbate 80  
sodium chloride  
butylated hydroxytoluene  
 
Product Characteristics
Color PINK Score no score 
Shape ROUND Size 8mm
Flavor  Imprint Code 10;XL 
Contains     
 
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50458-810-01 100 TABLET, EXTENDED RELEASE ( TABLET) in 1 BOTTLE None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020897 06/26/1999 

DITROPAN  XL
oxybutynin chloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-815
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
oxybutynin chloride (oxybutynin)  oxybutynin chloride 15 mg
 
Inactive Ingredients
Ingredient Name Strength
cellulose acetate  
hypromelloses  
lactose  
magnesium stearate