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Drug Product Composition: Bonuten

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

USFDA APPLICATION NUMBER - 18998 / DOSAGE - TABLET;ORAL - 2.5MG

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

Inactive Ingredients

Ingredient Name
NuCare Pharmaceuticals, Inc.
REMEDYREPACK INC.
A-S Medication Solutions
American Health Packaging
Cardinal Health
Lake Erie Medical DBA Quality Care Products LLC
Mylan Institutional Inc.
Mylan Pharmaceuticals Inc.
NCS HealthCare of KY, Inc dba Vangard Labs
NuCare Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc.
Unit Dose Services
Lek Pharmaceuticals, d.d.
Teva Pharmaceuticals USA, Inc.
Cronus Pharma LLC
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Preferred Pharmaceuticals Inc.
ALUMINUM OXIDE(LMI26O6933)                
ANHYDROUS LACTOSE(3SY5LH9PMK)      
BROWN IRON OXIDE(1N032N7MFO)          
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)               
CROSCARMELLOSE SODIUM(M28OL1HH48)                 
D&C RED NO. 27(2LRS185U6K)                 
D&C YELLOW NO. 10(35SW5USQ3G)                 
FD&C BLUE NO. 1(H3R47K3TBD)            
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)              
FERROSOFERRIC OXIDE(XM0M87F357)                 
FERROUS OXIDE(G7036X8B5H)                 
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)          
HYPROMELLOSES(3NXW29V3WO)                
LACTOSE MONOHYDRATE(EWQ57Q8I5X)            
LACTOSE(J2B2A4N98G)                 
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)               
MAGNESIUM STEARATE(70097M6I30)     
MALEIC ACID(91XW058U2C)            
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)              
SILICON DIOXIDE(ETJ7Z6XBU4)            
sodium bicarbonate(8MDF5V39QO)          
SODIUM LAURYL SULFATE(368GB5141J)            
SODIUM STEARATE(QU7E2XA9TG)               
STARCH, CORN(O8232NY3SJ) 
STEARIC ACID(4ELV7Z65AP)        
TALC(7SEV7J4R1U)        
WATER(059QF0KO0R)