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Drug Product Composition: Hydroxyzine

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$ API Ref.Price (USD/KG) : 153Xls

USFDA APPLICATION NUMBER - 88619 / DOSAGE - TABLET;ORAL - 50MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE HYDROCHLORIDE(UNII: 76755771U3)
(HYDROXYZINE - UNII:30S50YM8OG)
HYDROXYZINE HYDROCHLORIDE50mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
Glenmark Pharmaceuticals Inc., USA
PD-Rx Pharmaceuticals, Inc.
Qualitest Pharmaceuticals
REMEDYREPACK INC.
Bryant Ranch Prepack
Cardinal Health
Golden State Medical Supply
HARRIS Pharmaceutical, Inc.
Lake Erie Medical DBA Quality Care Products LLC
Mylan Institutional Inc.
Mylan Pharmaceuticals Inc.
NCS HealthCare of KY, Inc dba Vangard Labs
NuCare Pharmaceuticals, Inc.
Proficient Rx LP
QPharma Inc
St. Mary’s Medical Park Pharmacy
A-S Medication Solutions LLC
Preferred Pharmaceuticals, Inc.
Heritage Pharmaceuticals Inc.
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
American Health Packaging
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)                 
ANHYDROUS LACTOSE(3SY5LH9PMK)        
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)                     
CARNAUBA WAX(R12CBM0EIZ)              
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)        
CROSPOVIDONE (12 MPA.S AT 5%)(40UAA97IT9)                  
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)            
CROSPOVIDONE(2S7830E561)                    
CROSPOVIDONE(68401960MK)                  
CROSPOVIDONE, UNSPECIFIED(2S7830E561)                    
D&C YELLOW NO. 10(35SW5USQ3G)                   
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)                    
HYPROMELLOSE 2208 (3 MPA.S)(9H4L916OBU)                   
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)                     
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)                     
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)                  
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                
HYPROMELLOSES(3NXW29V3WO)        
LACTOSE MONOHYDRATE(EWQ57Q8I5X)       
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)            
POLYDEXTROSE(VH2XOU12IE)                
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)                    
POLYETHYLENE GLYCOL 400(B697894SGQ)                
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)                     
POLYETHYLENE GLYCOL(3WJQ0SDW1A)                    
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)          
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)              
POLYSORBATE 80(6OZP39ZG8H)         
POLYVINYL ALCOHOL(532B59J990)                    
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)                
POVIDONE(FZ989GH94E)                     
POVIDONES(FZ989GH94E)                    
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)                
WATER(059QF0KO0R)