Route of Administration ORAL
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
memantine hydrochloride (UNII: JY0WD0UA60) (memantine - UNII:W8O17SJF3T) memantine hydrochloride 14 mg
 
Inactive Ingredients
Ingredient Name Strength
sucrose (UNII: C151H8M554)  
povidone K30 (UNII: U725QWY32X)  
hypromellose 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
talc (UNII: 7SEV7J4R1U)  
polyethylene glycol 400 (UNII: B697894SGQ)  
polyethylene glycol 8000 (UNII: Q662QK8M3B)  
ethylcellulose (100 MPA.S) (UNII: 47MLB0F1MV)  
ammonia (UNII: 5138Q19F1X)  
Product Characteristics
Color yellow (YELLOW) , GREEN (DARK GREEN (OPAQUE)) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor  Imprint Code FLI;14;mg
Contains     
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022525 09/15/2011 
 
Part 3 of 4
NAMENDA  XR
 memantine hydrochloride capsule, extended release
 
Product Information

Route of Administration ORAL
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
memantine hydrochloride (UNII: JY0WD0UA60) (memantine - UNII:W8O17SJF3T) memantine hydrochloride 21 mg
 
Inactive Ingredients
Ingredient Name Strength
sucrose (UNII: C151H8M554)  
povidone K30 (UNII: U725QWY32X)  
hypromellose 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
talc (UNII: 7SEV7J4R1U)  
polyethylene glycol 400 (UNII: B697894SGQ)  
polyethylene glycol 8000 (UNII: Q662QK8M3B)  
ethylcellulose (100 MPA.S) (UNII: 47MLB0F1MV)  
ammonia (UNII: 5138Q19F1X)  
 
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) , GREEN (DARK GREEN (OPAQUE)) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor  Imprint Code FLI;21;mg
Contains     

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing En