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Drug Product Composition: Focalin

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$ API Ref.Price (USD/KG) : 5,085Xls

USFDA APPLICATION NUMBER - 21278 / DOSAGE - TABLET;ORAL - 2.5MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE(UNII: 1678OK0E08)
(DEXMETHYLPHENIDATE - UNII:M32RH9MFGP)
DEXMETHYLPHENIDATE HYDROCHLORIDE10mg | 5mg | 2.5mg

Inactive Ingredients

Ingredient Name
Avera McKennan Hospital
KVK-TECH, INC
Teva Pharmaceuticals USA, Inc.
Tris Pharma Inc
A-S Medication Solutions LLC
West-ward Pharmaceutical Corp
Sandoz Inc
Sun Pharmaceutical Industries, Inc.
Bryant Ranch Prepack
Golden State Medical Supply, Inc.
ALUMINUM OXIDE(LMI26O6933)         
ANHYDROUS LACTOSE(3SY5LH9PMK)       
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)      
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)        
D&C YELLOW NO. 10(35SW5USQ3G)    
FD&C BLUE NO. 1(H3R47K3TBD)  
FD&C BLUE NO. 2(L06K8R7DQK)         
FD&C RED NO. 3(PN2ZH5LOQY)      
GELATIN(2G86QN327L)      
LACTOSE MONOHYDRATE(EWQ57Q8I5X) 
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)         
SILICON DIOXIDE(ETJ7Z6XBU4)     
SODIUM LAURYL SULFATE(368GB5141J)      
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) 
STARCH, CORN(O8232NY3SJ)     
STARCH, PREGELATINIZED CORN(O8232NY3SJ)       
TALC(7SEV7J4R1U)        
TITANIUM DIOXIDE(15FIX9V2JP)