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Drug Product Composition: Zonisamide

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$ API Ref.Price (USD/KG) : 346Xls

USFDA APPLICATION NUMBER - 20789 / DOSAGE - CAPSULE;ORAL - 100MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZONISAMIDE(UNII: 459384H98V)
(ZONISAMIDE - UNII:459384H98V)
ZONISAMIDE25mg | 100mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
Apotex Corp.
Bryant Ranch Prepack
Dr. Reddy's Laboratories Limited
Lake Erie Medical DBA Quality Care Products LLC
Avera McKennan Hospital
Golden State Medical Supply Inc
PD-Rx Pharmaceuticals, Inc.
REMEDYREPACK INC.
Mylan Institutional Inc.
Mylan Pharmaceuticals Inc.
NCS HealthCare of KY, Inc dba Vangard Labs
American Health Packaging
Eisai Inc.
Eon Labs, Inc.
Zydus Pharmaceuticals (USA) Inc.
ALCOHOL(3K9958V90M)           
AMMONIA(5138Q19F1X)          
ANHYDROUS LACTOSE(3SY5LH9PMK)           
butyl alcohol(8PJ61P6TS3)           
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)   
D&C RED NO. 28(767IP0Y5NH)           
D&C YELLOW NO. 10(35SW5USQ3G)     
FD&C BLUE NO. 1(H3R47K3TBD)    
FD&C BLUE NO. 2(L06K8R7DQK)     
FD&C RED NO. 3(PN2ZH5LOQY)            
FD&C RED NO. 4(X3W0AM1JLX)               
FD&C RED NO. 40(WZB9127XOA)    
FD&C YELLOW NO. 5(I753WB2F1M)               
FD&C YELLOW NO. 6(H77VEI93A8)             
FERRIC OXIDE RED(1K09F3G675)              
FERROSOFERRIC OXIDE(XM0M87F357)   
GELATIN(2G86QN327L)   
GELATIN, UNSPECIFIED(2G86QN327L)            
HYDROGENATED CASTOR OIL(ZF94AP8MEY)              
HYDROGENATED COTTONSEED OIL(Z82Y2C65EA)               
HYDROGENATED SOYBEAN OIL(A2M91M918C)               
ISOPROPYL ALCOHOL(ND2M416302)              
MAGNESIUM STEARATE(70097M6I30)           
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)            
POTASSIUM HYDROXIDE(WZH3C48M4T)          
propylene glycol(6DC9Q167V3)    
SHELLAC(46N107B71O)    
SILICON DIOXIDE(ETJ7Z6XBU4)         
SODIUM LAURYL SULFATE(368GB5141J)      
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)               
STEARIC ACID(4ELV7Z65AP)               
TALC(7SEV7J4R1U)              
TITANIUM DIOXIDE(15FIX9V2JP) 
water(059QF0KO0R)