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Drug Product Composition: Bonuten

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$ API Ref.Price (USD/KG) : 194Xls

USFDA APPLICATION NUMBER - 19221 / DOSAGE - TABLET;ORAL - 5MG;12.5MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENALAPRIL MALEATE(UNII: 9O25354EPJ)
(ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM)
ENALAPRIL MALEATE10mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
HYDROCHLOROTHIAZIDE25mg

Inactive Ingredients

Ingredient Name
Cosette Pharmaceuticals, Inc.
Apotex Corp.
Lake Erie Medical DBA Quality Care Products LLC
Mylan Pharmaceuticals Inc.
REMEDYREPACK INC.
Bryant Ranch Prepack
Oceanside Pharmaceuticals
Aluminum Oxide(LMI26O6933)      
ANHYDROUS LACTOSE(3SY5LH9PMK)   
FD&C BLUE NO. 2(L06K8R7DQK)      
FD&C RED NO. 40(WZB9127XOA)      
FD&C YELLOW NO. 6(H77VEI93A8)      
FERRIC OXIDE RED(1K09F3G675)  
FERRIC OXIDE YELLOW(EX438O2MRT)      
LACTOSE MONOHYDRATE(EWQ57Q8I5X)     
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)      
MAGNESIUM STEARATE(70097M6I30)   
MALEIC ACID(91XW058U2C)      
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)      
SILICON DIOXIDE(ETJ7Z6XBU4)      
SODIUM BICARBONATE(8MDF5V39QO)    
SODIUM LAURYL SULFATE(368GB5141J)      
STARCH, CORN(O8232NY3SJ)   
WATER(059QF0KO0R)      
ZINC STEARATE(H92E6QA4FV)