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Drug Product Composition: Dextroamphetamine

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$ API Ref.Price (USD/KG) : 3,501Xls

USFDA APPLICATION NUMBER - 17078 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE(UNII: JJ768O327N)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI)
DEXTROAMPHETAMINE SULFATE15mg | 5mg | 10mg

Inactive Ingredients

Ingredient Name
American Health Packaging
Vensun Pharmaceuticals, LLC.
Mylan Pharmaceuticals Inc.
Amedra Pharmaceuticals LLC
Amneal Pharmaceuticals of New York LLC
Lineage Therapeutics Inc
Par Pharmaceutical
Avera McKennan Hospital
Teva Pharmaceuticals, USA, Inc.
Zydus Pharmaceuticals (USA) Inc.
Alcohol(3K9958V90M)        
ALUMINUM OXIDE(LMI26O6933)         
AMMONIA(5138Q19F1X)        
BUTYL ALCOHOL(8PJ61P6TS3)         
CETYL ALCOHOL(936JST6JCN)       
D&C RED NO. 28(767IP0Y5NH)         
D&C RED NO. 33(9DBA0SBB0L)        
D&C RED NO. 7(ECW0LZ41X8)         
D&C YELLOW NO. 10(35SW5USQ3G)  
DIBUTYL SEBACATE(4W5IH7FLNY) 
ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62)        
ETHYLCELLULOSE (100 MPA.S)(47MLB0F1MV)        
ETHYLCELLULOSE (20 MPA.S)(BJG0S321QY)         
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)      
ETHYLCELLULOSES(7Z8S9VYZ4B)        
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)    
GELATIN(2G86QN327L)    
GELATIN, UNSPECIFIED(2G86QN327L)     
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)         
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)         
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)         
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)         
HYPROMELLOSES(3NXW29V3WO)       
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)        
ISOPROPYL ALCOHOL(ND2M416302)         
MAGNESIUM STEARATE(70097M6I30)         
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)         
METHYLCELLULOSE (15 MPA.S)(NPU9M2E6L8)       
OLEIC ACID(2UMI9U37CP)        
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)         
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)      
POVIDONE K30(U725QWY32X)       
POVIDONE(FZ989GH94E)      
POVIDONE, UNSPECIFIED(FZ989GH94E)         
POVIDONES(FZ989GH94E)         
PROPYLENE GLYCOL(6DC9Q167V3)   
SHELLAC(46N107B71O)    
silicon dioxide(ETJ7Z6XBU4)     
SODIUM HYDROXIDE(55X04QC32I)         
SODIUM LAURYL SULFATE(368GB5141J)    
STARCH, CORN(O8232NY3SJ)     
SUCROSE(C151H8M554)    
TALC(7SEV7J4R1U)   
Titanium dioxide(15FIX9V2JP)   
WATER(059QF0KO0R)