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Drug Product Composition: Mirtazapine

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$ API Ref.Price (USD/KG) : 362Xls

USFDA APPLICATION NUMBER - 20415 / DOSAGE - TABLET;ORAL - 30MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIRTAZAPINE(UNII: A051Q2099Q)
(MIRTAZAPINE - UNII:A051Q2099Q)
MIRTAZAPINE45mg | 30mg | 15mg | 30mg | 15mg | 15mg | 30mg | 45mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
Actavis Pharma, Inc.
Bryant Ranch Prepack
Clinical Solutions Wholesale
McKesson Contract Packaging
NCS HealthCare of KY, Inc dba Vangard Labs
REMEDYREPACK INC.
Unit Dose Services
Organon USA Inc.
Cardinal Health
Lake Erie Medical Medical DBA Quality Care Products LLC
NuCare Pharmaceuticals, Inc.
NuCare Pharmaceuticals,Inc.
KAISER FOUNDATION HOSPITALS
Lake Erie Medical DBA Quality Care Products LLC
REMEDYREPACK INC.
Clinical Solutions Wholesale, LLC
McKesson Corporation dba RX Pak
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.
Eon Labs, Inc.
PD-Rx Pharmaceuticals, Inc.
McKesson Corporation
Proficient Rx LP
Teva Pharmaceuticals USA, Inc.
Avera McKennan Hospital
Northstar Rx LLC
ANHYDROUS LACTOSE(3SY5LH9PMK)                   
ASPARTAME(Z0H242BBR1)                          
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                   
CITRIC ACID MONOHYDRATE(2968PHW8QP)                          
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)                        
CROSCARMELLOSE SODIUM(M28OL1HH48)             
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                         
FD&C BLUE NO. 2(L06K8R7DQK)                        
FD&C YELLOW NO. 6(H77VEI93A8)                      
FERRIC OXIDE RED(1K09F3G675)      
FERRIC OXIDE YELLOW(EX438O2MRT)    
FERROSOFERRIC OXIDE(XM0M87F357)                     
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                        
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                 
Hydroxypropyl Cellulose (Type H)(RFW2ET671P)                     
HYDROXYPROPYL CELLULOSE (TYPE L)(UKE75GEA7F)                          
HYDROXYPROPYL CELLULOSE(RFW2ET671P)                       
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14)                     
HYDROXYPROPYL METHYLCELLULOSE E5 [II](R75537T0T4)                          
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)                     
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)                    
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)                          
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)                
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                
HYPROMELLOSES(3NXW29V3WO)               
LACTOSE MONOHYDRATE(EWQ57Q8I5X)    
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)                         
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(2165RE0K14)                        
MAGNESIUM STEARATE(70097M6I30) 
MANNITOL(3OWL53L36A)                          
MICROCRYSTALLINE CELLULOSE 102(PNR0YF693Y)                          
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                 
POLYDEXTROSE(VH2XOU12IE)                       
POLYETHYLENE GLYCOL 400(B697894SGQ)             
POLYETHYLENE GLYCOL 6000(30IQX730WE)                  
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)             
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                       
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                        
POLYSORBATE 80(6OZP39ZG8H)                   
POVIDONE K30(U725QWY32X)                    
POVIDONE(FZ989GH94E)                         
POVIDONE, UNSPECIFIED(FZ989GH94E)                         
SILICON DIOXIDE(ETJ7Z6XBU4)       
SODIUM BICARBONATE(8MDF5V39QO)                          
SODIUM LAURYL SULFATE(368GB5141J)                        
STARCH, CORN(O8232NY3SJ)        
SUCROSE(C151H8M554)                          
titanium dioxide(15FIX9V2JP) 
TRIACETIN(XHX3C3X673)