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Drug Product Composition: Eplerenone

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$ API Ref.Price (USD/KG) : 2,242Xls

USFDA APPLICATION NUMBER - 21437 / DOSAGE - TABLET;ORAL - 25MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPLERENONE(UNII: 6995V82D0B)
(EPLERENONE - UNII:6995V82D0B)
EPLERENONE25mg

Inactive Ingredients

Ingredient Name
Apotex Corp
Avera McKennan Hospital
American Health Packaging
Mylan Pharmaceuticals Inc.
Slate Run Pharmaceuticals, LLC
Upsher-Smith Laboratories, LLC
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)    
CROSCARMELLOSE SODIUM(M28OL1HH48)
FD&C YELLOW NO. 5(I753WB2F1M)     
FD&C YELLOW NO. 6(H77VEI93A8)     
FERRIC OXIDE RED(1K09F3G675)    
FERRIC OXIDE YELLOW(EX438O2MRT)   
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)     
HYPROMELLOSE 2208 (15000 MPA.S)(Z78RG6M2N2)     
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)  
HYPROMELLOSES(3NXW29V3WO)     
LACTOSE MONOHYDRATE(EWQ57Q8I5X)  
LACTOSE(J2B2A4N98G)     
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)  
POLYDEXTROSE(VH2XOU12IE)     
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)     
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)   
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)     
POLYSORBATE 80(6OZP39ZG8H)  
POVIDONE K30(U725QWY32X)     
SODIUM LAURYL SULFATE(368GB5141J)   
TALC(7SEV7J4R1U) 
TITANIUM DIOXIDE(15FIX9V2JP) 
TRIACETIN(XHX3C3X673)