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Drug Product Composition: Clavulanic Acid

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$ API Ref.Price (USD/KG) : 79Xls

USFDA APPLICATION NUMBER - 50720 / DOSAGE - TABLET;ORAL - 875MG;EQ 125MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)
AMOXICILLIN ANHYDROUS875mg | 250mg in 5
CLAVULANATE POTASSIUM(UNII: Q42OMW3AT8)
(CLAVULANIC ACID - UNII:23521W1S24)
CLAVULANIC ACID 1251
CLAVULANATE POTASSIUM(UNII: Q42OMW3AT8)
(CLAVULANIC ACID - UNII:23521W1S24)
CLAVULANIC ACID62.5mg in 5

Inactive Ingredients

Ingredient Name
Preferred Pharmaceuticals, Inc.
A-S Medication Solutions LLC
Neopharma Inc
Sandoz GmbH
Sandoz Inc
Avera McKennan Hospital
bryant ranch prepack
Clinical Solutions Wholesale
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
DIRECT RX
Hikma Pharmaceutical
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Lake Erie Medical DBA Quality Care Products LLC
Lek Pharmaceuticals, d.d.
MedVantx, Inc.
NuCare Pharmaceuticals, Inc.
NuCare Pharmaceuticals,Inc.
Quality Care Products, LLC
RedPharm Drug, Inc.
REMEDYREPACK INC.
Unit Dose Services
Mylan Pharmaceuticals Inc.
NorthStar Rx LLC
A-S Medication Solutions
Aurobindo Pharma Limited
Blenheim Pharmacal, Inc.
Micro Labs Limited
Proficient Rx LP
Hikma Pharmaceuticals USA Inc.
Preferred Pharmaceuticals Inc.
PD-Rx Pharmaceuticals, Inc.
RPK Pharmaceuticals, Inc.
USAntibiotics, LLC
ANHYDROUS CITRIC ACID(XF417D3PSL)                                
ASPARTAME(Z0H242BBR1)                             
BANANA(4AJZ4765R9)                               
CARAMEL(T9D99G2B1R)                                
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(K679OBS311)                                
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)               
CETYL ALCOHOL(936JST6JCN)                            
CHERRY(BUC5I9595W)                               
Colloidal silicon dioxide(ETJ7Z6XBU4)                                
croscarmellose sodium (M28OL1HH48)                                
CROSCARMELLOSE SODIUM(M28OL1HH48)                         
crospovidone (68401960MK)                                
CROSPOVIDONE (120 .MU.M)(68401960MK)                              
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                            
CROSPOVIDONE(2S7830E561)                               
CROSPOVIDONE(68401960MK)                        
CROSPOVIDONE, UNSPECIFIED(2S7830E561)                                
ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62)                           
ethylcellulose(7Z8S9VYZ4B)                                
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)                         
ETHYLCELLULOSES(7Z8S9VYZ4B)                     
FD&C RED NO. 40(WZB9127XOA)                               
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                                
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                               
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)                           
hydroxypropyl cellulose(RFW2ET671P)                                
HYPROMELLOSE 2910 (15000 MPA.S)(288VBX44JC)                       
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)                          
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)                            
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)              
ORANGE(5EVU04N5QU)                              
POLYDEXTROSE(VH2XOU12IE)                          
POLYETHYLENE GLYCOL 400(B697894SGQ)                            
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)                       
POLYETHYLENE GLYCOL 6000(30IQX730WE)                       
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)                          
POLYETHYLENE GLYCOL(3WJQ0SDW1A)                              
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                            
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                              
POLYSORBATE 80(6OZP39ZG8H)                        
PROPYLENE GLYCOL(6DC9Q167V3)                             
RASPBERRY(4N14V5R27W)                                
SACCHARIN SODIUM DIHYDRATE(SB8ZUX40TY)                                
SACCHARIN SODIUM(SB8ZUX40TY)                              
SILICON DIOXIDE(ETJ7Z6XBU4) 
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)                                
SODIUM LAURYL SULFATE(368GB5141J)                            
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)   
SUCCINIC ACID(AB6MNQ6J6L)                              
TALC(7SEV7J4R1U)                
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)                          
TRIETHYL CITRATE(8Z96QXD6UM)                     
XANTHAN GUM(TTV12P4NEE)