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Drug Product Composition: Hydroxyzine Pamoate

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$ API Ref.Price (USD/KG) : 188Xls

USFDA APPLICATION NUMBER - 11459 / DOSAGE - CAPSULE;ORAL - EQ 50MG HYDROCHLORIDE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE PAMOATE(UNII: M20215MUFR)
(HYDROXYZINE - UNII:30S50YM8OG)
HYDROXYZINE50mg

Inactive Ingredients

Ingredient Name
Avera McKennan Hospital
Cardinal Health
Mylan Institutional Inc.
Heritage Pharmaceuticals Inc.
Lake Erie Medical DBA Quality Care Products LLC
NuCare Pharmaceuticals, Inc.
NuCare Pharmaceuticals,Inc.
REMEDYREPACK INC.
St. Mary's Medical Park Pharmacy
REMEDYREPACK INC.
A-S Medication Solutions
A-S Medication Solutions LLC
Actavis Pharma, Inc.
American Health Packaging
AvKARE, Inc.
Bryant Ranch Prepack
Golden State Medical Supply, Inc.
NCS HealthCare of KY, Inc dba Vangard Labs
NCS HealthCare of KY, LLC dba Vangard Labs
PD-Rx Pharmaceuticals, Inc.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.
Proficient Rx LP
ALUMINUM OXIDE(LMI26O6933)                     
ANHYDROUS LACTOSE(3SY5LH9PMK)                     
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                 
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)                      
CROSCARMELLOSE SODIUM(M28OL1HH48)                   
D&C RED NO. 28(767IP0Y5NH)                     
D&C RED NO. 33(9DBA0SBB0L)                   
D&C YELLOW NO. 10(35SW5USQ3G) 
FD&C BLUE NO. 1(H3R47K3TBD)   
FD&C BLUE NO. 2(L06K8R7DQK)               
FD&C GREEN NO. 3(3P3ONR6O1S)               
FD&C RED NO. 40(WZB9127XOA)      
FD&C YELLOW NO. 6(H77VEI93A8)    
FERROSOFERRIC OXIDE(XM0M87F357)        
GELATIN(2G86QN327L)            
GELATIN, UNSPECIFIED(2G86QN327L)                
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                     
HYDROXYPROPYL CELLULOSE (1200000 WAMW)(U3JF91U133)                      
HYDROXYPROPYL CELLULOSE (TYPE E)(66O7AQV0RT)                      
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)                   
HYDROXYPROPYL CELLULOSE(RFW2ET671P)                      
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)                    
LACTOSE MONOHYDRATE(EWQ57Q8I5X)             
MAGNESIUM STEARATE(70097M6I30) 
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                 
PROPYLENE GLYCOL(6DC9Q167V3)              
SHELLAC(46N107B71O)               
SILICON DIOXIDE(ETJ7Z6XBU4)        
SODIUM LAURYL SULFATE(368GB5141J)   
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)      
STARCH, CORN(O8232NY3SJ)    
SUCROSE(C151H8M554)                      
TITANIUM DIOXIDE(15FIX9V2JP)