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Drug Product Composition: Memantine HCl

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

USFDA APPLICATION NUMBER - 21487 / DOSAGE - TABLET;ORAL - 5MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEMANTINE HYDROCHLORIDE(UNII: JY0WD0UA60)
(memantine - UNII:W8O17SJF3T)
MEMANTINE HYDROCHLORIDE10mg

Inactive Ingredients

Ingredient Name
Bryant Ranch Prepack
Lupin Pharmaceuticals, Inc.
Jubilant Cadista Pharmaceuticals Inc.
Orchid Chemicals & Pharmaceuticals Limited
Golden State Medical Supply, Inc.
Amneal Pharmaceuticals LLC
AvKARE, Inc.
CELLTRION USA, INC.
Hikma Pharmaceutical
POLYGEN PHARMACEUTICALS INC.
PuraCap Pharmaceutical LLC
Strides Pharma Science Limited
Torrent Pharmaceuticals Limited
Vivimed Labs Limited
Wockhardt USA LLC.
Zydus Pharmaceuticals (USA) Inc.
Cardinal Health
Mylan Institutional Inc.
Mylan Pharmaceuticals Inc.
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
PD-Rx Pharmaceuticals, Inc.
ALUMINUM OXIDE(LMI26O6933)                   
Anhydrous Lactose(3SY5LH9PMK)                   
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)                    
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)     
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)                   
CROSCARMELLOSE SODIUM(M28OL1HH48)   
CROSPOVIDONE(68401960MK)                    
D&C YELLOW NO. 10(35SW5USQ3G)                   
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)                    
FD&C BLUE NO. 2(L06K8R7DQK)         
Fd&c Yellow No. 6(H77VEI93A8)        
FERRIC OXIDE RED(1K09F3G675)                  
FERRIC OXIDE YELLOW(EX438O2MRT)                 
FERROSOFERRIC OXIDE(XM0M87F357)      
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                    
HYPROMELLOSE 2910 (10000 MPA.S)(0HO1H52958)                    
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)                    
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)                
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                 
hypromelloses(3NXW29V3WO)          
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)                   
magnesium stearate(70097M6I30)  
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                 
POLYETHYLENE GLYCOL 400(B697894SGQ)             
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)                    
POLYETHYLENE GLYCOL 6000(30IQX730WE)                    
POLYETHYLENE GLYCOL(3WJQ0SDW1A)                    
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)              
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                    
POLYSORBATE 80(6OZP39ZG8H)                    
POLYVINYL ALCOHOL (100000 MW)(949E52Z6MY)                    
POLYVINYL ALCOHOL(532B59J990)                    
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)                    
POVIDONE(FZ989GH94E)                    
SILICON DIOXIDE(ETJ7Z6XBU4)     
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)                    
SODIUM STEARYL FUMARATE(7CV7WJK4UI)                    
TALC(7SEV7J4R1U)    
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)