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Drug Product Composition: Oxymorphone HCl

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USFDA APPLICATION NUMBER - 201655 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYMORPHONE HYDROCHLORIDE(UNII: 5Y2EI94NBC)
(OXYMORPHONE - UNII:9VXA968E0C)
OXYMORPHONE HYDROCHLORIDE30mg | 40mg

Inactive Ingredients

Ingredient Name
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Lake Erie Medical DBA Quality Care Products LLC
Endo Pharmaceuticals Inc.
SpecGx LLC
Actavis Pharma, Inc.
Quality Care Products, LLC
.ALPHA.-TOCOPHEROL(H4N855PNZ1)    
ALPHA-TOCOPHEROL(H4N855PNZ1)     
ALUMINUM OXIDE(LMI26O6933)    
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)   
CITRIC ACID MONOHYDRATE(2968PHW8QP)   
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)  
HYPROMELLOSE 2208 (100000 MPA.S)(VM7F0B23ZI)     
HYPROMELLOSES(3NXW29V3WO) 
LACTOSE MONOHYDRATE(EWQ57Q8I5X)    
MAGNESIUM STEARATE(70097M6I30)  
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)     
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)  
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)    
POLYVINYL ALCOHOL(532B59J990)    
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)  
SILICON DIOXIDE(ETJ7Z6XBU4)   
TALC(7SEV7J4R1U) 
TITANIUM DIOXIDE(15FIX9V2JP)
XANTHAN GUM(TTV12P4NEE)