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Drug Product Composition: Valacyclovir Hydrochloride

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$ API Ref.Price (USD/KG) : 226Xls

USFDA APPLICATION NUMBER - 20487 / DOSAGE - TABLET;ORAL - EQ 500MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE(UNII: G447S0T1VC)
(ACYCLOVIR - UNII:X4HES1O11F)
VALACYCLOVIR HYDROCHLORIDE500mg

Inactive Ingredients

Ingredient Name
MedVantx, Inc.
State of Florida DOH Central Pharmacy
Avera McKennan Hospital
Cardinal Health
REMEDYREPACK INC.
Chartwell RX, LLC
Yiling Pharmaceutical, Inc.
A-S Medication Solutions
Bryant Ranch Prepack
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
PD-Rx Pharmaceuticals, Inc.
ACETRIS HEALTH, LLC
Actavis Pharma, Inc.
Aidarex Pharmaceuticals LLC
Clinical Solutions Wholesale
Direct Rx
Lake Erie Medical DBA Quality Care Products LLC
NuCare Pharmaceuticals, Inc.
NuCare Pharmaceuticals,Inc.
NuCare Pharmacuticals,Inc.
Wockhardt Limited
Wockhardt USA LLC.
Zydus Pharmaceuticals (USA) Inc.
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.
Teva Pharmaceuticals USA, Inc.
Golden State Medical Supply, Inc.
SUN PHARMACEUTICAL INDUSTRIES, INC.
Proficient Rx LP
REMEDYREPACK INC.
West-Ward Pharmaceuticals Corp.
ALUMINUM OXIDE(LMI26O6933)                              
AMMONIA(5138Q19F1X)                             
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)                              
CARNAUBA WAX(R12CBM0EIZ)                          
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)             
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)                               
CROSCARMELLOSE SODIUM(M28OL1HH48)                
CROSPOVIDONE (120 .MU.M)(68401960MK)                               
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                       
CROSPOVIDONE(2S7830E561)                             
CROSPOVIDONE(68401960MK)                      
CROSPOVIDONE, UNSPECIFIED(2S7830E561)                               
FD&C BLUE NO. 2(L06K8R7DQK)    
FERROSOFERRIC OXIDE(XM0M87F357)                             
HYDROGENATED CASTOR OIL(ZF94AP8MEY)                         
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                               
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                             
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)                             
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)                           
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)                
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                      
HYPROMELLOSES(3NXW29V3WO)                
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)                              
LACTOSE MONOHYDRATE(EWQ57Q8I5X)                               
MAGNESIUM STEARATE(70097M6I30)     
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                       
POLYETHYLENE GLYCOL 400(B697894SGQ)         
POLYETHYLENE GLYCOL 6000(30IQX730WE)                          
POLYETHYLENE GLYCOL(3WJQ0SDW1A)                               
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                     
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                      
POLYSORBATE 80(6OZP39ZG8H)     
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)                               
POVIDONE K90(RDH86HJV5Z)               
POVIDONE(FZ989GH94E)                            
POVIDONE, UNSPECIFIED(FZ989GH94E)                         
POVIDONES(FZ989GH94E)                         
POWDERED CELLULOSE(SMD1X3XO9M)                            
PROPYLENE GLYCOL(6DC9Q167V3)                             
SHELLAC(46N107B71O)                             
SILICON DIOXIDE(ETJ7Z6XBU4)                         
SODIUM STEARYL FUMARATE(7CV7WJK4UI)                            
STARCH, CORN(O8232NY3SJ)                      
TALC(7SEV7J4R1U)                           
TITANIUM DIOXIDE(15FIX9V2JP)