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Drug Product Composition: Morphine Sulfate

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$ API Ref.Price (USD/KG) : 15,454Xls

USFDA APPLICATION NUMBER - 206544 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C)
MORPHINE SULFATE100mg | 60mg | 30mg | 15mg

Inactive Ingredients

Ingredient Name
Daiichi Sankyo Inc.
Inspirion Delivery Technologies, Llc
Sun Pharmaceutical Industries, Inc.
McKesson Corporation
St Marys Medical Park Pharmacy
Zydus Pharmaceuticals (USA) Inc.
Bryant Ranch Prepack
Cardinal Health
DIRECT RX
Lake Erie Medical DBA Quality Care Products LLC
PD-Rx Pharmaceuticals, Inc.
Watson Laboratories, Inc.
Lupin Pharmaceuticals,Inc.
Novel Laboratories, Inc.
Quality Care Products, LLC
bryant ranch prepack
American Health Packaging
Mylan Pharmaceuticals Inc.
Par Pharmaceutical
ALGINIC ACID(8C3Z4148WZ)                 
ALUMINUM OXIDE(LMI26O6933)                  
AMMONIA(5138Q19F1X)                 
ANHYDROUS LACTOSE(3SY5LH9PMK)                
BUTYL ALCOHOL(8PJ61P6TS3)                 
BUTYLATED HYDROXYANISOLE(REK4960K2U)                  
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)                  
CARNAUBA WAX(R12CBM0EIZ)                 
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                  
CETOSTEARYL ALCOHOL(2DMT128M1S)            
D&C RED NO. 27(2LRS185U6K)            
D&C RED NO. 30(2S42T2808B)               
D&C RED NO. 7(ECW0LZ41X8)             
D&C YELLOW NO. 10(35SW5USQ3G)           
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW)(XRK36F13ZZ)                 
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(P2OM2Q86BI)                 
FD&C BLUE NO. 1(H3R47K3TBD)    
FD&C BLUE NO. 2(L06K8R7DQK)        
FD&C RED NO. 40(WZB9127XOA)              
FD&C YELLOW NO. 5(I753WB2F1M)                  
FD&C YELLOW NO. 6(H77VEI93A8)          
FERRIC OXIDE RED(1K09F3G675)                
FERRIC OXIDE YELLOW(EX438O2MRT)              
FERROSOFERRIC OXIDE(XM0M87F357)           
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(8136Y38GY5)               
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)(S38J6RZN16)                  
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)(12VCE9HR9E)                  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)(ZYD53NBL45)                 
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)                  
hydroxypropyl cellulose(RFW2ET671P)                 
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14)                 
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)                 
HYPROMELLOSE 2208 (15000 MPA.S)(Z78RG6M2N2)                  
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)                 
HYPROMELLOSE(3NXW29V3WO)                 
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)             
HYPROMELLOSES(3NXW29V3WO)             
ISOPROPYL ALCOHOL(ND2M416302)                 
LACTOSE MONOHYDRATE(EWQ57Q8I5X)      
lactose(J2B2A4N98G)              
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)                  
MAGNESIUM STEARATE(70097M6I30) 
MANNITOL(3OWL53L36A)                 
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                  
POLYDEXTROSE(VH2XOU12IE)                  
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)                 
POLYETHYLENE GLYCOL 400(B697894SGQ)                
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)                
polyethylene glycol(3WJQ0SDW1A)              
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)              
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)               
polysorbate 80(6OZP39ZG8H)        
POLYVINYL ALCOHOL(532B59J990)                  
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)                
POVIDONE, UNSPECIFIED(FZ989GH94E)                
POWDERED CELLULOSE(SMD1X3XO9M)                
PROPYLENE GLYCOL(6DC9Q167V3)                 
SHELLAC(46N107B71O)                 
SILICON DIOXIDE(ETJ7Z6XBU4)        
SODIUM ALGINATE(C269C4G2ZQ)                 
STEARIC ACID(4ELV7Z65AP)           
TALC(7SEV7J4R1U)       
TITANIUM DIOXIDE(15FIX9V2JP)   
TRIACETIN(XHX3C3X673)                  
XANTHAN GUM(TTV12P4NEE)