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Drug Product Composition: Azithromycin

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

USFDA APPLICATION NUMBER - 50784 / DOSAGE - TABLET;ORAL - EQ 500MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN ANHYDROUS(UNII: J2KLZ20U1M)
(AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)
AZITHROMYCIN ANHYDROUS500mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
Bryant Ranch Prepack
Clinical Solutions Wholesale
Lake Erie Medical DBA Quality Care Products LLC
PD-Rx Pharmaceuticals, Inc.
REMEDYREPACK INC.
Aidarex Pharmaceuticals LLC
Alembic Pharmaceuticals Inc.
Bionpharma Inc.
DIRECT RX
Major Pharmaceuticals
NuCare Pharmaceuticals, Inc.
NuCare Pharmaceuticals,Inc.
Preferred Pharmaceuticals, Inc.
Proficient Rx LP
REMEDYREPACK INC.
RPK Pharmaceuticals, Inc.
Teva Pharmaceuticals USA, Inc.
Unit Dose Services
American Health Packaging
LUPIN LIMITED
Lupin Pharmaceuticals, Inc.
Quality Care Products, LLC
AvPAK
Lannett Company, Inc.
Sunshine Lake Pharma Co., Ltd.
Vivimed Labs Limited
Wockhardt USA LLC.
Apotex Corp.
Preferred Pharmaceuticals Inc.
Sandoz Inc
ALUMINUM OXIDE(LMI26O6933)                         
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)              
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)                          
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)                    
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP)                              
CARMINIC ACID(CID8Z8N95N)                            
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                   
COCHINEAL(TZ8Z31B35M)                             
CROSCARMELLOSE SODIUM(M28OL1HH48)     
D&C RED NO. 30(2S42T2808B)                
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)                          
FD&C BLUE NO. 1(H3R47K3TBD)                              
FD&C BLUE NO. 2(L06K8R7DQK)                        
FD&C RED NO. 40(WZB9127XOA)                         
FD&C YELLOW NO. 6(H77VEI93A8)                         
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                              
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                            
HYDROXYPROPYL CELLULOSE (70000 WAMW)(66O7AQV0RT)                              
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)                          
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)                         
HYDROXYPROPYL CELLULOSE(RFW2ET671P)                            
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)           
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                          
HYPROMELLOSES(3NXW29V3WO)                    
LACTOSE MONOHYDRATE(EWQ57Q8I5X)           
LACTOSE(J2B2A4N98G)                            
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)                             
LECITHIN, SOYBEAN(1DI56QDM62)                          
MAGNESIUM STEARATE(70097M6I30) 
MAGNESIUM TRISILICATE(C2E1CI501T)                   
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                     
PIGMENT RED 5(91OZU993LX)                              
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)                              
POLYETHYLENE GLYCOL 400(B697894SGQ)                          
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)                        
POLYETHYLENE GLYCOL(3WJQ0SDW1A)                              
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                      
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                           
POLYVINYL ALCOHOL(532B59J990)                             
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)                           
SILICON DIOXIDE(ETJ7Z6XBU4)            
SODIUM LAURYL SULFATE(368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)                           
STARCH, CORN(O8232NY3SJ)         
STARCH, PREGELATINIZED CORN(O8232NY3SJ)                            
TALC(7SEV7J4R1U)                    
titanium dioxide(15FIX9V2JP) 
TRIACETIN(XHX3C3X673)         
TRISODIUM CITRATE DIHYDRATE(B22547B95K)                        
XANTHAN GUM(TTV12P4NEE)