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Drug Product Composition: Morphine Sulfate

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

USFDA APPLICATION NUMBER - 20616 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C)
MORPHINE SULFATE20mg

Inactive Ingredients

Ingredient Name
Pfizer Laboratories Div Pfizer Inc
Actavis Kadian LLC
Actavis Pharma, Inc.
Allergan, Inc.
Bryant Ranch Prepack
Lake Erie Medical DBA Quality Care Products LLC
Par Pharmaceutical Inc.
Watson Laboratories, Inc.
St Marys Medical Park Pharmacy
AMMONIO METHACRYLATE COPOLYMER TYPE A(8GQS4E66YY)        
D&C RED NO. 28(767IP0Y5NH)  
D&C YELLOW NO. 10(35SW5USQ3G)
DIETHYL PHTHALATE(UF064M00AF) 
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)     
ETHYLCELLULOSES(7Z8S9VYZ4B)   
FD&C BLUE NO. 1(H3R47K3TBD) 
FD&C BLUE NO. 2(L06K8R7DQK)      
FD&C GREEN NO. 3(3P3ONR6O1S)     
FD&C RED NO. 3(PN2ZH5LOQY) 
FD&C RED NO. 40(WZB9127XOA) 
FD&C YELLOW NO. 6(H77VEI93A8)   
FERRIC OXIDE BLACK(XM0M87F357)        
FERRIC OXIDE RED(1K09F3G675)     
FERRIC OXIDE YELLOW(EX438O2MRT)     
FERROSOFERRIC OXIDE(XM0M87F357)   
FUMARIC ACID(88XHZ13131)      
GELATIN(2G86QN327L) 
GELATIN, UNSPECIFIED(2G86QN327L)     
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)       
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)     
HYPROMELLOSES(3NXW29V3WO)    
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)      
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)   
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)        
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)        
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)        
POLYETHYLENE GLYCOL 6000(30IQX730WE)       
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)      
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)      
POTASSIUM HYDROXIDE(WZH3C48M4T)    
POVIDONE (FZ989GH94E)        
POVIDONE K30(U725QWY32X)       
POVIDONES(FZ989GH94E)       
PROPYLENE GLYCOL(6DC9Q167V3)  
SHELLAC(46N107B71O)    
SILICON DIOXIDE(ETJ7Z6XBU4)   
SODIUM LAURYL SULFATE(368GB5141J)  
STARCH, CORN(O8232NY3SJ) 
SUCROSE(C151H8M554) 
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)