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Drug Product Composition: Amlodipine Besylate

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$ API Ref.Price (USD/KG) : 117Xls

USFDA APPLICATION NUMBER - 20364 / DOSAGE - CAPSULE;ORAL - EQ 10MG BASE;40MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288)
AMLODIPINE BESYLATE2.5mg
BENAZEPRIL HYDROCHLORIDE(UNII: N1SN99T69T)
(BENAZEPRIL - UNII:UDM7Q7QWP8)
BENAZEPRIL HYDROCHLORIDE10mg

Inactive Ingredients

Ingredient Name
Apotex Corp.
Bryant Ranch Prepack
NuCare Pharmaceuticals,Inc.
PD-Rx Pharmaceuticals, Inc.
Teva Pharmaceuticals USA, Inc.
A-S Medication Solutions
Actavis Pharma, Inc.
BluePoint Laboratories
Lupin Pharmaceuticals, Inc.
Mylan Pharmaceuticals Inc.
Proficient Rx LP
Cardinal Health
Clinical Solutions Wholesale
Lake Erie Medical DBA Quality Care Products LLC
NCS HealthCare of KY, Inc dba Vangard Labs
Sandoz Inc
NuCare Pharmaceuticals, Inc.
Aidarex Pharmaceuticals LLC
NuCare Pharmaceuticals, Inc.
Par Pharmaceutical Inc.
Rebel Distributors Corp
REMEDYREPACK INC.
Ammonia(5138Q19F1X)                     
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)                  
ANHYDROUS LACTOSE(3SY5LH9PMK)               
CALCIUM PHOSPHATE(97Z1WI3NDX)                
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)                    
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)          
CROSPOVIDONE (120 .MU.M)(68401960MK)                   
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)              
CROSPOVIDONE(2S7830E561)                     
CROSPOVIDONE(68401960MK)        
CROSPOVIDONE, UNSPECIFIED(2S7830E561)                  
D&C RED NO. 28(767IP0Y5NH)             
D&C YELLOW NO. 10(35SW5USQ3G)                 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)                  
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. 5(I753WB2F1M)                   
FD&C YELLOW NO. 6(H77VEI93A8)                   
FERRIC OXIDE RED(1K09F3G675)       
FERRIC OXIDE YELLOW(EX438O2MRT)              
FERROSOFERRIC OXIDE(XM0M87F357)        
GELATIN(2G86QN327L)     
GELATIN, UNSPECIFIED(2G86QN327L)            
HYDROGENATED CASTOR OIL(ZF94AP8MEY)               
HYPROMELLOSE(3NXW29V3WO)                     
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                  
HYPROMELLOSES(3NXW29V3WO)                 
LACTOSE MONOHYDRATE(EWQ57Q8I5X)               
LACTOSE(J2B2A4N98G)                
MAGNESIUM STEARATE(70097M6I30) 
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)            
POLYDEXTROSE(VH2XOU12IE)                     
POLYETHYLENE GLYCOL 400(B697894SGQ)                 
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                     
POLYSORBATE 80(6OZP39ZG8H)           
POTASSIUM HYDROXIDE(WZH3C48M4T)               
POVIDONE K30(U725QWY32X)             
POVIDONE(FZ989GH94E)                    
POVIDONE, UNSPECIFIED(FZ989GH94E)                     
Propylene glycol(6DC9Q167V3)            
SHELLAC(46N107B71O)        
SILICON DIOXIDE(ETJ7Z6XBU4) 
SODIUM LAURYL SULFATE(368GB5141J)        
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)      
STARCH, CORN(O8232NY3SJ)       
STEARIC ACID(4ELV7Z65AP)                     
Talc(7SEV7J4R1U)          
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)