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Drug Product Composition: Memantine

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$ API Ref.Price (USD/KG) : 548Xls

USFDA APPLICATION NUMBER - 22525 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 14MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEMANTINE HYDROCHLORIDE(UNII: JY0WD0UA60)
(memantine - UNII:W8O17SJF3T)
MEMANTINE HYDROCHLORIDE7mg

Inactive Ingredients

Ingredient Name
Apotex Corp
Avera McKennan Hospital
Mylan Pharmaceuticals Inc.
NorthStar RxLLC
Golden State Medical Supply, Inc.
Lupin Pharmaceuticals, Inc.
Major Pharmaceuticals
Par Pharmaceutical, Inc.
Bryant Ranch Prepack
NCS HealthCare of KY, Inc dba Vangard Labs
AMMONIA(5138Q19F1X)      
BUTYL ALCOHOL(8PJ61P6TS3)         
D&C YELLOW NO. 10(35SW5USQ3G)     
ETHYLCELLULOSE (100 MPA.S)(47MLB0F1MV)        
ETHYLCELLULOSE (7 MPA.S)(H3UP11403C)         
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)       
ETHYLCELLULOSES(7Z8S9VYZ4B)      
FD&C BLUE NO. 1(H3R47K3TBD)    
FD&C BLUE NO. 2(L06K8R7DQK)       
FD&C GREEN NO. 3(3P3ONR6O1S)        
FD&C RED NO. 40(WZB9127XOA)      
FD&C YELLOW NO. 6(H77VEI93A8)       
FERRIC OXIDE RED(1K09F3G675)        
FERRIC OXIDE YELLOW(EX438O2MRT)     
FERROSOFERRIC OXIDE(XM0M87F357)  
GELATIN(2G86QN327L)     
GELATIN, UNSPECIFIED(2G86QN327L)      
HYDROXYPROPYL CELLULOSE (70000 WAMW)(66O7AQV0RT)         
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)         
HYDROXYPROPYL CELLULOSE (TYPE E)(66O7AQV0RT)         
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)         
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)        
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)         
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)       
HYPROMELLOSES(3NXW29V3WO)        
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)        
METHYLCELLULOSE (15 MPA.S)(NPU9M2E6L8)         
OLEIC ACID(2UMI9U37CP)        
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)        
POLYETHYLENE GLYCOL 400(B697894SGQ)       
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)        
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)         
POLYSORBATE 80(6OZP39ZG8H)         
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)        
POTASSIUM HYDROXIDE(WZH3C48M4T)      
POVIDONE K30(U725QWY32X)        
PROPYLENE GLYCOL(6DC9Q167V3)    
SHELLAC(46N107B71O)  
SILICON DIOXIDE(ETJ7Z6XBU4)         
SODIUM LAURYL SULFATE(368GB5141J)        
STARCH, CORN(O8232NY3SJ)   
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)  
TRIETHYL CITRATE(8Z96QXD6UM)