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Drug Product Composition: Amoxicillin Trihydrate

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$ API Ref.Price (USD/KG) : 32Xls

USFDA APPLICATION NUMBER - 50760 / DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)
AMOXICILLIN ANHYDROUS400mg in 5 | 500mg | 875mg | 200mg in 5

Inactive Ingredients

Ingredient Name
DAVA Pharmaceuticals Inc
Sandoz GmbH
Teva Pharmaceuticals USA, Inc.
Lake Erie Medical DBA Quality Care Products LLC
NuCare Pharmaceuticals,Inc.
RPK Pharmaceuticals, Inc.
Morton Grove Pharmaceuticals, Inc.
DIRECT RX
Dr Reddys Laboratories Inc
Proficient Rx LP
A-S Medication Solutions
Aidarex Pharmaceuticals LLC
Aurobindo Pharma Limited
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.
Rising Pharma Holdings, Inc.
A-S Medication Solutions LLC
Hikma Pharmaceutical
Hikma Pharmaceuticals USA Inc.
REMEDYREPACK INC.
ALCOHOL(3K9958V90M)                  
AMMONIA(5138Q19F1X)                 
ANHYDROUS CITRIC ACID(XF417D3PSL)               
ANHYDROUS LACTOSE(3SY5LH9PMK)                   
ANHYDROUS TRISODIUM CITRATE(RS7A450LGA)              
BUTYL ALCOHOL(8PJ61P6TS3)                  
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                
CROSCARMELLOSE SODIUM(M28OL1HH48)                   
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                 
CROSPOVIDONE(2S7830E561)                   
CROSPOVIDONE(68401960MK)                   
D&C RED NO. 28(767IP0Y5NH)                   
D&C RED NO. 30(2S42T2808B)                  
D&C YELLOW NO. 10 ALUMINUM LAKE(CQ3XH3DET6)                   
D&C YELLOW NO. 10(35SW5USQ3G)                   
EDETATE DISODIUM(7FLD91C86K)          
ETHYLCELLULOSES(7Z8S9VYZ4B)                  
FD&C BLUE NO. 1 ALUMINUM LAKE(J9EQA3S2JM)                   
FD&C BLUE NO. 1(H3R47K3TBD)                   
FD&C BLUE NO. 2 ALUMINUM LAKE(4AQJ3LG584)                   
FD&C RED NO. 3(PN2ZH5LOQY)        
FD&C RED NO. 40(WZB9127XOA)           
FERRIC OXIDE YELLOW(EX438O2MRT)                  
FERROSOFERRIC OXIDE(XM0M87F357)                 
GELATIN(2G86QN327L)                  
GELATIN, UNSPECIFIED(2G86QN327L)                   
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                   
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)                   
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)                 
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                  
HYPROMELLOSES(3NXW29V3WO)               
ISOPROPYL ALCOHOL(ND2M416302)                  
LACTOSE MONOHYDRATE(EWQ57Q8I5X)                   
MAGNESIUM STEARATE(70097M6I30)              
MANNITOL(3OWL53L36A)                   
METHYLPARABEN(A2I8C7HI9T)                   
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                  
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                   
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                   
POLYSORBATE 80(6OZP39ZG8H)                   
POTASSIUM HYDROXIDE(WZH3C48M4T)                 
PROPYLENE GLYCOL(6DC9Q167V3)                 
PROPYLPARABEN(Z8IX2SC1OH)                   
SHELLAC(46N107B71O)                 
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM BENZOATE(OJ245FE5EU)
SODIUM CITRATE(1Q73Q2JULR)                
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)                  
SODIUM LAURYL SULFATE(368GB5141J)                   
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)                
SODIUM(9NEZ333N27)                  
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)                 
TITANIUM DIOXIDE(15FIX9V2JP)              
TRIACETIN(XHX3C3X673)                   
TRIETHYL CITRATE(8Z96QXD6UM)                  
TRISODIUM CITRATE DIHYDRATE(B22547B95K)      
WATER(059QF0KO0R)                  
XANTHAN GUM(TTV12P4NEE)